Manufacturer registered with FDA
Prismatik Dentalcraft, Inc.
Irvine, CA, United States. Lists 27 dental device types with FDA across 2 registered establishments, and holds 56 510(k) clearances as applicant.
- Device types listed
- 27
- Brands and models
- 5,024
- 510(k) clearances
- 562010–2026
- Markets registered in
- 551 registrations outside the US
- Establishments
- 2United States
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Prismatik Dentalcraft, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Prismatik Dentalcraft, Inc. | 56 clearances | 2010–2026 | Below |
| Colombia | INVIMA | Registration holder | PRISMATIK DENTALCRAFT, INCPRISMATIK DENTALCRAFT , INC · PRISMATIK DENTAL CRAFT, INC. | 27 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | PRISMATIK DENTALCRAFT, INC.PRISMATIK DENTALCRAFT INC | 21 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Prismatik Dentalcraft Inc.Prismatik Dentalcraft, Inc. | 2 | 2011–2013 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Prismatik Dentalcraft, Inc. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Prismatik Dentalcraft, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A1BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A2BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A3BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A3.5BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A4BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, B1BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, B2BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, B3BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, B4BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, Bleach White 1,376 moreBruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, Bleach1BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, Bleach3BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, C1BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, C2BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, C3BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, C4BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, D2BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, D3BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, D4BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, A1BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, A2BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, A3BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, A3.5BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, A4BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, B1BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, B2BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, B3BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, B4BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, Bleach WhiteBruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, Bleach1BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, Bleach3BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, C1BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, C2BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, C3BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, C4BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, D2BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, D3BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, D4BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, A1BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, A2BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, A3BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, A3.5BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, A4BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, B1BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, B2BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, B3BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, B4BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, Bleach WhiteBruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, Bleach1BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, Bleach3BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, C1BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, C2BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, C3BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, C4BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, D2BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, D3BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, D4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm x 3 mmP, D2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD 3 mmP, A3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, A1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, A2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, A3.5BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, A4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, B1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, B2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, B3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, B4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, Bleach WhiteBruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, Bleach1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, Bleach3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, C1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, C2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, C3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, C4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, D3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, D4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A3.5BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, B1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, B2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, B3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, B4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, Bleach WhiteBruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, Bleach1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, Bleach3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, C1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, C2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, C3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, C4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, D2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, D3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, D4BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A1BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A2BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A3BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A3.5BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A4BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, B1BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, B2BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, B3BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, B4BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD X 4.5 mmP, Bleach WhiteBruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, Bleach1BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD X 4.5 mmP, Bleach3BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, C1BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, C2BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, C4BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, D2BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, D3BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, D4BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD, C3Custom Impression Coping Screw for Zimmer Screw-VentEsthetic Abutment, Anterior, 15 Degree Angle for Astra 3Esthetic Abutment, Anterior, 15 Degree Angle for Astra 3.5/4Esthetic Abutment, Anterior, 15 Degree Angle for Astra 4.5/5Esthetic Abutment, Anterior, 15 Degree Angle for CAMLOG SCREW-LINE 3.3 mmEsthetic Abutment, Anterior, 15 Degree Angle for CAMLOG SCREW-LINE 3.8 mmEsthetic Abutment, Anterior, 15 Degree Angle for CAMLOG SCREW-LINE 4.3 mmEsthetic Abutment, Anterior, Straight for Astra 3Esthetic Abutment, Anterior, Straight for Astra 3.5/4Esthetic Abutment, Anterior, Straight for Astra 4.5/5Esthetic Abutment, Anterior, Straight for CAMLOG SCREW-LINE 3.3 mmEsthetic Abutment, Anterior, Straight for CAMLOG SCREW-LINE 3.8 mmEsthetic Abutment, Anterior, Straight for CAMLOG SCREW-LINE 4.3 mmEsthetic Abutment, Posterior, 15 Degree Angle for Astra 3.5/4Esthetic Abutment, Posterior, 15 Degree Angle for Astra 4.5/5Esthetic Abutment, Posterior, 15 Degree Angle for CAMLOG SCREW-LINE 4.3 mmEsthetic Abutment, Posterior, 15 Degree Angle for CAMLOG SCREW-LINE 5 mmEsthetic Abutment, Posterior, Straight for Astra 3.5/4Esthetic Abutment, Posterior, Straight for Astra 4.5/5Esthetic Abutment, Posterior, Straight for CAMLOG SCREW-LINE 4.3 mmEsthetic Abutment, Posterior, Straight for CAMLOG SCREW-LINE 5 mmGlidewell HT Implant GL Titanium Abutment 4.5 mmH - 3 ImplantGlidewell HT Implant GL Titanium Abutment 4.5 mmH - 3.5/4.3 ImplantGlidewell HT Implant GL Titanium Abutment 4.5 mmH - 5 ImplantGlidewell HT Implant GL Titanium Abutment 4.5 mmH - 6 ImplantGlidewell HT Implant GL Titanium Abutment 4.5 mmH - 7 ImplantGlidewell HT Implant GL Titanium Abutment 6 mmH - 3 ImplantGlidewell HT Implant GL Titanium Abutment 6 mmH - 3.5/4.3 ImplantGlidewell HT Implant GL Titanium Abutment 6 mmH - 5 ImplantGlidewell HT Implant GL Titanium Abutment 6 mmH - 6 ImplantGlidewell HT Implant GL Titanium Abutment 6 mmH - 7 ImplantGlidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH 3.5/4.3 ImplantGlidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH 5 ImplantGlidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH 6 ImplantGlidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH 7 ImplantGlidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH - 3 Implant | 2013 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | BruxZir Basic Shade Coloring Liquid A1BruxZir Basic Shade Coloring Liquid A2BruxZir Basic Shade Coloring Liquid A3BruxZir Basic Shade Coloring Liquid A3.5BruxZir Basic Shade Coloring Liquid A4BruxZir Basic Shade Coloring Liquid B1BruxZir Basic Shade Coloring Liquid B2BruxZir Basic Shade Coloring Liquid B3BruxZir Basic Shade Coloring Liquid B4BruxZir Basic Shade Coloring Liquid C1 1,459 moreBruxZir Basic Shade Coloring Liquid C2BruxZir Basic Shade Coloring Liquid C3BruxZir Basic Shade Coloring Liquid C4BruxZir Basic Shade Coloring Liquid D2BruxZir Basic Shade Coloring Liquid D3BruxZir Basic Shade Coloring Liquid D4BruxZir Basic Shade Coloring Liquid -0M1BruxZir Basic Shade Coloring Liquid -0M3BruxZir Basic Shade Coloring Liquid -DiluteBruxZir Block, GD 10mm ZZBruxZir Block, GD 10mm ZZ - NotchBruxZir Block, GD 10mm ZZ - Notch - 5/pkBruxZir Block, GD 12mm D - 1/pkBruxZir Block, GD 12mm D - 5/pkBruxZir Block, GD 12mm R - 1/pkBruxZir Block, GD 12mm R - 5/pkBruxZir Block, GD 12mm Standard - 5/pkBruxZir Block, GD 12mm Z - 1/pkBruxZir Block, GD 12mm Z - 5/pkBruxZir Block, GD 14mm Nash Sales - 5/pkBruxZir Block, GD 14mm ZZBruxZir Block, GD 14mm ZZ - NotchBruxZir Block, GD 14mm ZZ - Notch - 5/pkBruxZir Block, GD 15mm D - 1/pkBruxZir Block, GD 15mm D - 5/pkBruxZir Block, GD 15mm LBruxZir Block, GD 15mm R - 1/pkBruxZir Block, GD 15mm R - 5/pkBruxZir Block, GD 15mm Standard - 1/pkBruxZir Block, GD 15mm Standard - 5/pkBruxZir Block, GD 15mm Z - 1/pkBruxZir Block, GD 15mm Z - 5/pkBruxZir Block, GD 18mm ZZBruxZir Block, GD 18mm ZZ - NotchBruxZir Block, GD 18mm ZZ - Notch - 5/pkBruxZir Block, GD 20mm D - 1/pkBruxZir Block, GD 20mm D - 5/pkBruxZir Block, GD 20mm OSZ, 1pkBruxZir Block, GD 20mm OSZ, 5 pkBruxZir Block, GD 20mm R - 1/pkBruxZir Block, GD 20mm R - 5/pkBruxZir Block, GD 20mm Standard - 1/pkBruxZir Block, GD 20mm Standard - 5/pkBruxZir Block, GD 20mm Z - 1/pkBruxZir Block, GD 20mm Z - 5/pkBruxZir Block, GD 22mm ZZBruxZir Block, GD 22mm ZZ - Notch 1 pkBruxZir Block, GD 22mm ZZ - Notch 5 pkBruxZir Block, GD 25mm D - 1/pkBruxZir Block, GD 25mm D - 4/pkBruxZir Block, GD 25mm OSZ, 1pkBruxZir Block, GD 25mm OSZ, 4 pkBruxZir Block, GD 25mm RBruxZir Block, GD 25mm R - 4/pkBruxZir Block, GD 25mm Standard - 1/pkBruxZir Block, GD 25mm Standard - 4/pkBruxZir Block, GD 25mm Z - 1/pkBruxZir Block, GD 25mm Z - 4/pkBruxZir Block, GD 30mm D - 4/pkBruxZir Block, GD 30mm Standard - 1/pkBruxZir Block, GD 30mm Standard - 4/pkBruxZir Block, GD 30mm Standard -1/pkBruxZir Block, GD 30mm Z - 1/PKBruxZir Block, GD 30mm Z - 4/PKBruxZir Coloring Liquids KitBruxZir Esthetic GL Single Unit Block - A1BruxZir Esthetic GL Single Unit Block - A2BruxZir Esthetic GL Single Unit Block - A3BruxZir Esthetic GL Single Unit Block - A3.5BruxZir Esthetic GL Single Unit Block - A4BruxZir Esthetic GL Single Unit Block - B1BruxZir Esthetic GL Single Unit Block - B2BruxZir Esthetic GL Single Unit Block - B3BruxZir Esthetic GL Single Unit Block - B4BruxZir Esthetic GL Single Unit Block - BleachBruxZir Esthetic GL Single Unit Block - C1BruxZir Esthetic GL Single Unit Block - C2BruxZir Esthetic GL Single Unit Block - C3BruxZir Esthetic GL Single Unit Block - C4BruxZir Esthetic GL Single Unit Block - D2BruxZir Esthetic GL Single Unit Block - D3BruxZir Esthetic GL Single Unit Block - D4BruxZir Esthetic GL Single Unit Block - WhiteBruxZir Esthetic NOW Block - A1BruxZir Esthetic NOW Block - A2BruxZir Esthetic NOW Block - A3BruxZir Esthetic NOW Block - A3.5BruxZir Esthetic NOW Block - A4BruxZir Esthetic NOW Block - B1BruxZir Esthetic NOW Block - B2BruxZir Esthetic NOW Block - B3BruxZir Esthetic NOW Block - B4BruxZir Esthetic NOW Block - Bleach 1BruxZir Esthetic NOW Block - Bleach WhiteBruxZir Esthetic NOW Block - C1BruxZir Esthetic NOW Block - C2BruxZir Esthetic NOW Block - C3BruxZir Esthetic NOW Block - C4BruxZir Esthetic NOW Block - D2BruxZir Esthetic NOW Block - D3BruxZir Esthetic NOW Block - D4BruxZir Esthetic NOW Posterior Block - A1BruxZir Esthetic NOW Posterior Block - A2BruxZir Esthetic NOW Posterior Block - A3BruxZir Esthetic NOW Posterior Block - A3.5BruxZir Esthetic NOW Posterior Block - A4BruxZir Esthetic NOW Posterior Block - B1BruxZir Esthetic NOW Posterior Block - B2BruxZir Esthetic NOW Posterior Block - B3BruxZir Esthetic NOW Posterior Block - B4BruxZir Esthetic NOW Posterior Block - Bleach 1BruxZir Esthetic NOW Posterior Block - Bleach WhiteBruxZir Esthetic NOW Posterior Block - C1BruxZir Esthetic NOW Posterior Block - C2BruxZir Esthetic NOW Posterior Block - C3BruxZir Esthetic NOW Posterior Block - C4BruxZir Esthetic NOW Posterior Block - D2BruxZir Esthetic NOW Posterior Block - D3BruxZir Esthetic NOW Posterior Block - D4BruxZir GT (Gum Tissue) ColorBruxZir Incisal Coloring Liquid - PearlBruxZir Incisal Coloring Liquid - PremiumBruxZir Incisal Coloring Liquid - Premium HTBruxzir Liquid Bulk, A1Bruxzir Liquid Bulk, A2Bruxzir Liquid Bulk, A3Bruxzir Liquid Bulk, A3.5Bruxzir Liquid Bulk, A4Bruxzir Liquid Bulk, B1Bruxzir Liquid Bulk, B2Bruxzir Liquid Bulk, B3Bruxzir Liquid Bulk, B4Bruxzir Liquid Bulk, C1Bruxzir Liquid Bulk, C2Bruxzir Liquid Bulk, C3Bruxzir Liquid Bulk, C4Bruxzir Liquid Bulk, D2Bruxzir Liquid Bulk, D3Bruxzir Liquid Bulk, D4Bruxzir Liquid, A1 | 2013 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | DreamTAPElastic Mandibular Advancement (EMA) applianceEndSnorZ Sleep Appliance, ENDSNZ, ENDSNZU, ENDSNZLflexTAP®OASYS Hinge ApplianceSilent Nite Sleep ApplianceSilent Nite® 3D Sleep Appliance, MA-PC-SD-OP, MA-PC-SD-UA, MA-PC-SD-LASilent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG)TAP IITAP III 1 moreTAP T | 2013 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Abutment ScrewClosed-Tray Impression ScrewClosed-Tray Tranfer 3.5 x 3.5 x 8Closed-Tray Transfer 4.5 x 4.5 x 8Closed-Tray Transfer 4.5 x 5.7 x 8Cortical Bone Drill 1.7Cover Screw 4.5Drill ExtenderGlidewell HT Implant 15° Anterior Esthetic Abutment - 3 ImplantGlidewell HT Implant 15° Anterior Esthetic Abutment - 3.5/4.3 Implant 516 moreGlidewell HT Implant 15° Anterior Esthetic Abutment - 5 ImplantGlidewell HT Implant 15° Posterior Esthetic Abutment - 5 ImplantGlidewell HT Implant 17° Multi-Unit Abutment 2.5 mmH - 3.5/4.3 ImplantGlidewell HT Implant 17° Multi-Unit Abutment 2.5 mmH - 5 ImplantGlidewell HT Implant 17° Multi-Unit Abutment 3.5 mmH - 3.5/4.3 ImplantGlidewell HT Implant 17° Multi-Unit Abutment 3.5 mmH - 5 ImplantGlidewell HT Implant 3 x 11.5 mmGlidewell HT Implant 3 x 13 mmGlidewell HT Implant 3 x 16 mmGlidewell HT Implant 3.5 x 10 mmGlidewell HT Implant 3.5 x 11.5 mmGlidewell HT Implant 3.5 x 13 mmGlidewell HT Implant 3.5 x 16 mmGlidewell HT Implant 3.5 x 8 mmGlidewell HT Implant 30° Multi-Unit Abutment 3.5 mmH - 3.5/4.3 ImplantGlidewell HT Implant 30° Multi-Unit Abutment 3.5 mmH - 5 ImplantGlidewell HT Implant 30° Multi-Unit Abutment 4.5 mmH - 3.5/4.3 ImplantGlidewell HT Implant 30° Multi-Unit Abutment 4.5 mmH - 5 ImplantGlidewell HT Implant 4.3 x 10 mmGlidewell HT Implant 4.3 x 11.5 mmGlidewell HT Implant 4.3 x 13 mmGlidewell HT Implant 4.3 x 16 mmGlidewell HT Implant 4.3 x 8 mmGlidewell HT Implant 5 x 10 mmGlidewell HT Implant 5 x 11.5 mmGlidewell HT Implant 5 x 13 mmGlidewell HT Implant 5 x 16 mmGlidewell HT Implant 5 x 8 mmGlidewell HT Implant 6 x 10 mmGlidewell HT Implant 6 x 11.5 mmGlidewell HT Implant 6 x 8 mmGlidewell HT Implant 7 x 10 mmGlidewell HT Implant 7 x 11.5 mmGlidewell HT Implant 7 x 8 mmGlidewell HT Implant Angled Multi-Unit Abutment Screw - 3.5/4.3 ImplantGlidewell HT Implant Angled Multi-Unit Abutment Screw - 5 ImplantGlidewell HT Implant Anterior Esthetic Abutment - 3 ImplantGlidewell HT Implant Anterior Esthetic Abutment - 3.5/4.3 ImplantGlidewell HT Implant Anterior Esthetic Abutment - 5 ImplantGlidewell HT Implant Direction Indicator 3 mmGlidewell HT Implant Direction Indicator 3.5 mmGlidewell HT Implant Direction Indicator 4.3 mmGlidewell HT Implant Direction Indicator 5 mmGlidewell HT Implant Direction Indicator 7 mmGlidewell HT Implant GL Titanium Abutment 4.5 mmH - 3 ImplantGlidewell HT Implant GL Titanium Abutment 4.5 mmH - 3.5/4.3 ImplantGlidewell HT Implant GL Titanium Abutment 4.5 mmH - 5 ImplantGlidewell HT Implant GL Titanium Abutment 4.5 mmH - 6 ImplantGlidewell HT Implant GL Titanium Abutment 4.5 mmH - 7 ImplantGlidewell HT Implant GL Titanium Abutment 6 mmH - 3 ImplantGlidewell HT Implant GL Titanium Abutment 6 mmH - 3.5/4.3 ImplantGlidewell HT Implant GL Titanium Abutment 6 mmH - 5 ImplantGlidewell HT Implant GL Titanium Abutment 6 mmH - 6 ImplantGlidewell HT Implant GL Titanium Abutment 6 mmH - 7 ImplantGlidewell HT Implant Healing Abutment 3 mmH - 3 ImplantGlidewell HT Implant Healing Abutment 3 mmH - 3.5 ImplantGlidewell HT Implant Healing Abutment 3 mmH - 4.3 ImplantGlidewell HT Implant Healing Abutment 3 mmH - 5 ImplantGlidewell HT Implant Healing Abutment 3 mmH - 6 ImplantGlidewell HT Implant Healing Abutment 3 mmH - 7 ImplantGlidewell HT Implant Healing Abutment 5 mmH - 3 ImplantGlidewell HT Implant Healing Abutment 5 mmH - 3.5 ImplantGlidewell HT Implant Healing Abutment 5 mmH - 4.3 ImplantGlidewell HT Implant Healing Abutment 5 mmH - 5 ImplantGlidewell HT Implant Healing Abutment 5 mmH - 6 ImplantGlidewell HT Implant Healing Abutment 5 mmH - 7 ImplantGlidewell HT Implant Healing Abutment 7 mmH - 3 ImplantGlidewell HT Implant Healing Abutment 7 mmH - 3.5 ImplantGlidewell HT Implant Healing Abutment 7 mmH - 4.3 ImplantGlidewell HT Implant Healing Abutment 7 mmH - 5 ImplantGlidewell HT Implant Multi-Unit Abutment 1.5 mmH - 3.5/4.3 ImplantGlidewell HT Implant Multi-Unit Abutment 1.5 mmH - 5 ImplantGlidewell HT Implant Multi-Unit Abutment 1.5 mmH - 6 ImplantGlidewell HT Implant Multi-Unit Abutment 2.5 mmH - 3 ImplantGlidewell HT Implant Multi-Unit Abutment 2.5 mmH - 3.5/4.3 ImplantGlidewell HT Implant Multi-Unit Abutment 2.5 mmH - 5 ImplantGlidewell HT Implant Multi-Unit Abutment 2.5 mmH - 6 ImplantGlidewell HT Implant Multi-Unit Abutment 3.5 mmH - 3 ImplantGlidewell HT Implant Multi-Unit Abutment 3.5 mmH - 3.5/4.3 ImplantGlidewell HT Implant Multi-Unit Abutment 3.5 mmH - 5 ImplantGlidewell HT Implant Multi-Unit Abutment 3.5 mmH - 6 ImplantGlidewell HT Implant Multi-Unit Abutment 4.5 mmH - 5 ImplantGlidewell HT Implant Multi-Unit Abutment 4.5 mmH - 6 ImplantGlidewell HT Implant Non-Engaging Temporary Abutment - 3 ImplantGlidewell HT Implant Non-Engaging Temporary Abutment - 3.5/4.3 ImplantGlidewell HT Implant Non-Engaging Temporary Abutment - 5 ImplantGlidewell HT Implant Non-Engaging Temporary Abutment - 6 ImplantGlidewell HT Implant Non-Engaging Temporary Abutment - 7 ImplantGlidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH - 3 ImplantGlidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH - 3.5/4.3 ImplantGlidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH - 5 ImplantGlidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH - 6 ImplantGlidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH - 7 ImplantGlidewell HT Implant Non-Engaging UCLA Gold - 3 ImplantGlidewell HT Implant Non-Engaging UCLA Gold - 3.5/4.3 ImplantGlidewell HT Implant Non-Engaging UCLA Gold - 5 ImplantGlidewell HT Implant Non-Engaging UCLA Gold - 6 ImplantGlidewell HT Implant Non-Engaging UCLA Gold - 7 ImplantGlidewell HT Implant Posterior Esthetic Abutment 6 ImplantGlidewell HT Implant Posterior Esthetic Abutment - 5 ImplantGlidewell HT Implant Posterior Esthetic Abutment - 7 ImplantGlidewell HT Implant Temporary Abutment - 3 ImplantGlidewell HT Implant Temporary Abutment - 3.5/4.3 ImplantGlidewell HT Implant Temporary Abutment - 5 ImplantGlidewell HT Implant Temporary Abutment - 6 ImplantGlidewell HT Implant Temporary Abutment - 7 ImplantGlidewell HT Implant Titanium Abutment 4.5 mmH - 3 ImplantGlidewell HT Implant Titanium Abutment 4.5 mmH - 3.5/4.3 ImplantGlidewell HT Implant Titanium Abutment 4.5 mmH - 5 ImplantGlidewell HT Implant Titanium Abutment 4.5 mmH - 6 ImplantGlidewell HT Implant Titanium Abutment 4.5 mmH - 7 ImplantGlidewell HT Implant Titanium Abutment 6 mmH - 3 ImplantGlidewell HT Implant Titanium Abutment 6 mmH - 3.5/4.3 ImplantGlidewell HT Implant Titanium Abutment 6 mmH - 5 ImplantGlidewell HT Implant Titanium Abutment 6 mmH - 6 ImplantGlidewell HT Implant Titanium Abutment 6 mmH - 7 ImplantGlidewell HT Implant Titanium Abutment Blank 5 ImplantGlidewell HT Implant Titanium Abutment Blank 7 ImplantGlidewell HT Implant Titanium Abutment Blank - 3 ImplantGlidewell HT Implant Titanium Abutment Blank - 3.5/4.3 ImplantGlidewell HT Implant Titanium Abutment Blank - 6 ImplantGlidewell HT Implant Titanium Screw - 3 ImplantGlidewell HT Implant Titanium Screw - 3.5/4.3 ImplantGlidewell HT Implant Titanium Screw - 5/7 ImplantGlidewell HT Implant Titanium Screw 5/6 ImplantGlidewell HT Implant UCLA Gold - 3 ImplantGlidewell HT Implant UCLA Gold - 3.5/4.3 ImplantGlidewell HT Implant UCLA Gold - 5 ImplantGlidewell HT Implant UCLA Gold - 6 ImplantGlidewell HT Implant UCLA Gold - 7 ImplantGlidewell IH Angled Multi-Unit Abutment ScrewGlidewell IH Implant 15° Titanium Esthetic Abutment, Anterior, 3 mmP x 1.5 mmHGlidewell IH Implant 15° Titanium Esthetic Abutment, Anterior, 3 mmP x 2.3 mmHGlidewell IH Implant 15° Titanium Esthetic Abutment, Anterior, 3.5 mmPGlidewell IH Implant 15° Titanium Esthetic Abutment, Anterior, 3.5 mmP x 1.5 mmHGlidewell IH Implant 15° Titanium Esthetic Abutment, Anterior, 4.5 mmPGlidewell IH Implant 15° Titanium Esthetic Abutment, Anterior, 4.5 mmP x 1.5 mmHGlidewell IH Implant 15° Titanium Esthetic Abutment, Posterior, 4.5 mmPGlidewell IH Implant 3.2 mmD x 10 mmL x 3 mmPGlidewell IH Implant 3.2 mmD x 11.5 mmL x 3 mmP | 2013 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | BioTemps NOW Milling Block;Bridge Block;A1 (5-pack)BioTemps NOW Milling Block;Bridge Block;A2 (5-pack)BioTemps NOW Milling Block;Bridge Block;A3 (5-pack)BioTemps NOW Milling Block;Bridge Block;A3.5 (5-pack)BioTemps NOW Milling Block;Bridge Block;B1 (5-pack)BioTemps NOW Milling Block;Bridge Block;BL (5-pack)BioTemps NOW Milling Block;Bridge Block;C2 (5-pack)Flexible Partial Resin Shade G1Flexible Partial Resin Shade G3Flexible Partial Resin Shade G4 6 moreGlidewell 3DP Denture Base Resin - Shade G1Glidewell 3DP Denture Base Resin - Shade G3Glidewell 3DP Denture Base Resin - Shade G4Glidewell Denture Base Resin Shade G1Glidewell Denture Base Resin Shade G3Glidewell Denture Base Resin Shade G4 | 2021 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | BioTemps NOW Milling Block;Bridge Block;A1 (5-pack)BioTemps NOW Milling Block;Bridge Block;A2 (5-pack)BioTemps NOW Milling Block;Bridge Block;A3 (5-pack)BioTemps NOW Milling Block;Bridge Block;A3.5 (5-pack)BioTemps NOW Milling Block;Bridge Block;B1 (5-pack)BioTemps NOW Milling Block;Bridge Block;BL (5-pack)BioTemps NOW Milling Block;Bridge Block;C2 (5-pack)BioTemps NOW Milling Blocks; GD-Mandrel; A1 (5 units)BioTemps NOW Milling Blocks; GD-Mandrel; A2 (5 units)BioTemps NOW Milling Blocks; GD-Mandrel; A3 (5 units) 5 moreBioTemps NOW Milling Blocks; GD-Mandrel; A3.5 (5 units)BioTemps NOW Milling Blocks; GD-Mandrel; B1 (5 units)BioTemps NOW Milling Blocks; GD-Mandrel; BL (5 units)BioTemps NOW Milling Blocks; GD-Mandrel; C2 (5 units)CAMouflage NOW Milling Blocks; GD-Mandrel; A2 LT; 14 (5 units) | 2016 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2018 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | CAMouflage NOW Milling Blocks; GD-Mandrel; A1 HT; 14 (5 units)CAMouflage NOW Milling Blocks; GD-Mandrel; A1 LT; 14 (5 units)CAMouflage NOW Milling Blocks; GD-Mandrel; A2 HT; 14 (5 units)CAMouflage NOW Milling Blocks; GD-Mandrel; A2 LT; 14 (5 units)CAMouflage NOW Milling Blocks; GD-Mandrel; A3 HT; 14 (5 units)CAMouflage NOW Milling Blocks; GD-Mandrel; A3 LT; 14 (5 units)CAMouflage NOW Milling Blocks; GD-Mandrel; A3.5 HT; 14 (5 units)CAMouflage NOW Milling Blocks; GD-Mandrel; A3.5 LT; 14 (5 units)CAMouflage NOW Milling Blocks; GD-Mandrel; B1 HT; 14 (5 units)CAMouflage NOW Milling Blocks; GD-Mandrel; B1 LT; 14 (5 units) 4 moreCAMouflage NOW Milling Blocks; GD-Mandrel; Bleach; 14 (5 units)CAMouflage NOW Milling Blocks; GD-Mandrel; C2 LT; 14 (5 units)CAMouflage NOW Milling Blocks; GD-Mandrel; D2 LT; 14 (5 units)CAMouflage NOW Milling Blocks; GD-Mandrel; Variety Shade Pack; 14 (5 units) | 2016 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | BruxZir Adjustment & Polishing KitBruxZir Adjustment and Polishing KitBruxZir Blue Polishing Disc (3-pack) RefillBruxZir Blue Polishing Disc, 3/PkBruxZir Brown Polishing Cup (3-pack)BruxZir Brown Polishing Cup, 3/PkBruxZir Brown Polishing Disc, 3/PkBruxZir Brown Polishing Disk (3-pack) RefillBruxZir Green Brown White Polishing Cup (3-pack)BruxZir Green Polishing Cup (3-pack) 4 moreBruxZir Green Polishing Cup, 3/PkBruxZir Polishing Cup set, 3/PkBruxZir White Polishing Cup (3-pack)BruxZir White Polishing Cup, 3/Pk | 2023 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | BruxZir Adjustment & Polishing KitBruxZir Bur Set 3/PkBruxZir Diamond Football Bur, 3/PkBruxZir Round Bur (018 mm), 3/PkBruxZir Tapered Bur (021 mm), 3/PkBruxZir® Diamond football Bur (3-pack)BruxZir® Round Bur 018mm (3-pack)BruxZir® Tapered Bur- 021mm (3-pack)BZ Round Football Tapered Burs (3-pack) | 2013 |
| Dental CementEMA · Class 2 | Dental cements | Lister | BruxZir Dual Cure Resin CementGlidewell RMGI cement | 2022 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Lister | — | 2020 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A1BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A2BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A3BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A3.5BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A4BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, B1BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, B2BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, B3BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, B4BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, Bleach White 105 moreBruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, Bleach1BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, Bleach3BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, C1BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, C2BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, C3BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, C4BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, D2BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, D3BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, D4BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, A1BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, A2BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, A3BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, A3.5BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, A4BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, B1BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, B2BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, B3BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, B4BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, Bleach WhiteBruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, Bleach1BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, Bleach3BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, C1BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, C2BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, C3BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, C4BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, D2BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, D3BruxZir® NOW SRC for Glidewell HT Implant System 5 mmD, D4BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, A1BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, A2BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, A3BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, A3.5BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, A4BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, B1BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, B2BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, B3BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, B4BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, Bleach WhiteBruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, Bleach1BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, Bleach3BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, C1BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, C2BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, C3BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, C4BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, D2BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, D3BruxZir® NOW SRC for Glidewell HT Implant System 7 mmD, D4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm x 3 mmP, D2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD 3 mmP, A3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, A1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, A2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, A3.5BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, A4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, B1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, B2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, B3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, B4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, Bleach WhiteBruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, Bleach1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, Bleach3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, C1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, C2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, C3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, C4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, D3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, D4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A3.5BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, B1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, B2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, B3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, B4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, Bleach WhiteBruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, Bleach1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, Bleach3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, C1BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, C2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, C3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, C4BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, D2BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, D3BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, D4BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A1BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A2BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A3BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A3.5BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A4BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, B1BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, B2BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, B3BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, B4BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD X 4.5 mmP, Bleach WhiteBruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, Bleach1BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD X 4.5 mmP, Bleach3BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, C1BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, C2BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, C4BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, D2BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, D3BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, D4BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD, C3CloudPoint FastDesign Chairside | 2024 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | — | 2025 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | Glidewell Curing Light Kit | 2025 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | Newport Surgical Implant and Bone Grafting Instrument Kit | 2019 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | — | 2025 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Metal Quadrant Impression Trays, 250-PackMetal Quadrant Impression Trays, 50-Pack | 2023 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | 25 Automix Applicator Tips | 2023 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | ScanArt | 2016 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | Glidewell Zirconia Primer | 2022 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Glidewell TuffSplint Appliance Resin | 2023 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Lister | — | 2020 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Abutment Analog Snappy Abutment 4 for NobelReplace- 6/Bmk Syst- WP 5/pkAbutment Analog Snappy Abutment 4 for NobelReplace- NP 5/pkAbutment Analog Snappy Abutment 4 for NobelReplace- RP 5/pkAbutment Analog Snappy Abutment 4 for NobelReplace- WP 5/pkAbutment Analog Snappy Abutment 5.5 for NobelReplace- 6/Bmk Syst- WP 5/pkAbutment Analog Snappy Abutment 5.5 for NobelReplace- NP 5/pkAbutment Analog Snappy Abutment 5.5 for NobelReplace- RP 5/pkAbutment Analog Snappy Abutment 5.5 for NobelReplace- WP 5/pkAnalog, Snappy Abutment 4 c/w: Nobel Biocare NobelReplace 6Analog, Snappy Abutment 4 c/w: Nobel Biocare NobelReplace NP 1,410 moreAnalog, Snappy Abutment 4 c/w: Nobel Biocare NobelReplace RPAnalog, Snappy Abutment 4 c/w: Nobel Biocare NobelReplace WPAnalog, Snappy Abutment 5.5 c/w: Nobel Biocare NobelReplace 6Analog, Snappy Abutment 5.5 c/w: Nobel Biocare NobelReplace NPAnalog, Snappy Abutment 5.5 c/w: Nobel Biocare NobelReplace RPAnalog, Snappy Abutment 5.5 c/w: Nobel Biocare NobelReplace WPBite Ver. Cyl., NE, c/w: Biomet 3i TM Certain 4.1 mmBite Ver. Cyl., NE, c/w: Biomet 3i TM Certain 5 mmBite Ver. Cyl., NE, c/w: Biomet 3i TM Certain 6 mmBite Ver. Cyl., NE, c/w: Camlog Screw- Line 3.8 mmBite Ver. Cyl., NE, c/w: Camlog Screw- Line 6 mmBite Ver. Cyl., NE, c/w: Dentsply Implants Astra Tech Implant System 3.5/4Bite Ver. Cyl., NE, c/w: Dentsply Implants Astra Tech Implant System 4.5/5Bite Ver. Cyl., NE, c/w: Nobel Biocare Branemark System NPBite Ver. Cyl., NE, c/w: Nobel Biocare Branemark System RPBite Ver. Cyl., NE, c/w: NobelReplace 6Bite Ver. Cyl., NE, c/w: NobelReplace WPBite Ver. Cyl., NE, c/w: Zimmer Dental Screw-Vent 3.5 mmBite Ver. Cyl., NE, c/w: Zimmer Dental Screw-Vent 4.5 mmBite Ver. Cyl., NE, c/w: Zimmer Dental Screw-Vent 5.7 mmBite Verification Cylinder Engaging for Astra- 3Bite Verification Cylinder Engaging for Astra- 3.5/4Bite Verification Cylinder Engaging for Astra- 4.5/5Bite Verification Cylinder Engaging for Biomet 3i - Certain - 3.4 mmBite Verification Cylinder Engaging for Biomet 3i - Certain - 4.1 mmBite Verification Cylinder Engaging for Biomet 3i - Certain - 5 mmBite Verification Cylinder Engaging for Biomet 3i - Certain - 6 mmBite Verification Cylinder Engaging for Branemark System NPBite Verification Cylinder Engaging for Branemark System RPBite Verification Cylinder Engaging for Branemark System WPBite Verification Cylinder Engaging for CAMLOG SCREW-LINE 3.3 mmBite Verification Cylinder Engaging for CAMLOG SCREW-LINE 3.8 mmBite Verification Cylinder Engaging for CAMLOG SCREW-LINE 4.3 mmBite Verification Cylinder Engaging for CAMLOG SCREW-LINE 5 mmBite Verification Cylinder Engaging for CAMLOG SCREW-LINE 6 mmBite Verification Cylinder Engaging for NobelActive NPBite Verification Cylinder Engaging for NobelActive RPBite Verification Cylinder Engaging for NobelReplace 6Bite Verification Cylinder Engaging for NobelReplace NPBite Verification Cylinder Engaging for NobelReplace RPBite Verification Cylinder Engaging for NobelReplace WPBite Verification Cylinder Engaging for Straumann- Bone Level NCBite Verification Cylinder Engaging for Straumann- Bone Level RCBite Verification Cylinder Engaging for Zimmer Screw-Vent- 3.5 mmBite Verification Cylinder Engaging for Zimmer Screw-Vent- 4.5 mmBite Verification Cylinder Engaging for Zimmer Screw-Vent- 5.7 mmBite Verification Cylinder Non-Engaging for Biomet 3i - Certain - 3.4 mmBite Verification Cylinder Non-Engaging for Biomet 3i - Certain - 4.1 mmBite Verification Cylinder Non-Engaging for Biomet 3i - Certain - 5 mmBite Verification Cylinder Non-Engaging for Biomet 3i - Certain - 6 mmBite Verification Cylinder Non-Engaging for Branemark System WPBite Verification Cylinder Non-Engaging for CAMLOG SCREW-LINE 3.3 mmBite Verification Cylinder Non-Engaging for CAMLOG SCREW-LINE 3.8 mmBite Verification Cylinder Non-Engaging for CAMLOG SCREW-LINE 4.3 mmBite Verification Cylinder Non-Engaging for CAMLOG SCREW-LINE 5 mmBite Verification Cylinder Non-Engaging for CAMLOG SCREW-LINE 6 mmBite Verification Cylinder Non-Engaging for NobelActive NPBite Verification Cylinder Non-Engaging for NobelActive RPBite Verification Cylinder Non-Engaging for NobelReplace 6Bite Verification Cylinder Non-Engaging for NobelReplace NPBite Verification Cylinder Non-Engaging for NobelReplace RPBite Verification Cylinder Non-Engaging for NobelReplace WPBite Verification Cylinder Non-Engaging for Straumann- Bone Level RCBite Verification Cylinder Non-Engaging for Zimmer Screw-Vent- 4.5 mmBite Verification Cylinder Non-Engaging Multi Base for Nobelreplace NP/RPCortical Bone Drill 1.5Cortical Bone Drill 1.7Cortical Bone Drill 2.4Custom Impression Coping Screw for Astra 3Custom Impression Coping Screw for Astra 3.5/4Custom Impression Coping Screw for Astra 4.5/5Custom Impression Coping Screw for Biomet 3i CertainCustom Impression Coping Screw for Branemark System RPCustom Impression Coping Screw for NobelActive NPCustom Impression Coping Screw for NobelActive RPCustom Impression Coping Screw for NobelReplace NPCustom Impression Coping Screw for NobelReplace RP/WP/6DCustom Impression Coping Screw for Straumann Bone LevelCustom Impression Coping Screw for Zimmer Screw-VentDrill ExtenderDriver Handle - 5/pkGlidewell HT Digital Implant Analog - 3 ImplantGlidewell HT Digital Implant Analog - 3.5 ImplantGlidewell HT Digital Implant Analog - 4.3 ImplantGlidewell HT Digital Implant Analog - 5 ImplantGlidewell HT Digital Implant Analog - 6 ImplantGlidewell HT Digital Implant Analog - 7 ImplantGlidewell HT Digital Implant Analog Retention ScrewGlidewell HT Implant Analog - 3 ImplantGlidewell HT Implant Analog - 3.5 ImplantGlidewell HT Implant Analog - 4.3 ImplantGlidewell HT Implant Analog - 5 ImplantGlidewell HT Implant Analog - 6 ImplantGlidewell HT Implant Analog - 7 ImplantGlidewell HT Implant Bone Profiler - 3Glidewell HT Implant Bone Profiler - 3.5Glidewell HT Implant Bone Profiler - 4.3Glidewell HT Implant Bone Profiler - 5Glidewell HT Implant Bone Profiler - 6Glidewell HT Implant Closed-Tray Impression Coping 3 mmH 4.3 ImplantGlidewell HT Implant Closed-Tray Impression Coping 3 mmH 5 ImplantGlidewell HT Implant Closed-Tray Impression Coping 3 mmH 7 ImplantGlidewell HT Implant Closed-Tray Impression Coping 3 mmH - 3 ImplantGlidewell HT Implant Closed-Tray Impression Coping 3 mmH - 3.5 ImplantGlidewell HT Implant Closed-Tray Impression Coping 3 mmH - 6 ImplantGlidewell HT Implant Closed-Tray Impression Coping 5 mmH 4.3 ImplantGlidewell HT Implant Closed-Tray Impression Coping 5 mmH 5 ImplantGlidewell HT Implant Closed-Tray Impression Coping 5 mmH 7 ImplantGlidewell HT Implant Closed-Tray Impression Coping 5 mmH - 3 ImplantGlidewell HT Implant Closed-Tray Impression Coping 5 mmH - 3.5 ImplantGlidewell HT Implant Closed-Tray Impression Coping 5 mmH - 6 ImplantGlidewell HT Implant Closed-Tray Impression Coping 7 mmH 4.3 ImplantGlidewell HT Implant Closed-Tray Impression Coping 7 mmH 5 ImplantGlidewell HT Implant Closed-Tray Impression Coping 7 mmH - 3 ImplantGlidewell HT Implant Closed-Tray Impression Coping 7 mmH - 3.5 ImplantGlidewell HT Implant Direction Indicator 6 mmGlidewell HT Implant Driver 3 LongGlidewell HT Implant Driver 3.5/4.3 LongGlidewell HT Implant Driver 3.5/4.3 ShortGlidewell HT Implant Driver 5 LongGlidewell HT Implant Driver 5 ShortGlidewell HT Implant Driver 6 ShortGlidewell HT Implant Driver 7 ShortGlidewell HT Implant Guide Pin - 3 ImplantGlidewell HT Implant Guide Pin - 3.5/4.3 ImplantGlidewell HT Implant Guide Pin - 5/7 ImplantGlidewell HT Implant Guide Sleeve - 3 ImplantGlidewell HT Implant Guide Sleeve - 3.5 ImplantGlidewell HT Implant Guide Sleeve - 4.3 ImplantGlidewell HT Implant Guide Sleeve - 5 ImplantGlidewell HT Implant Guided Alignment Drill - 3 mmGlidewell HT Implant Guided Alignment Drill - 3.5 mmGlidewell HT Implant Guided Alignment Drill - 4.3/5 mmGlidewell HT Implant Guided Mount - 3 ImplantGlidewell HT Implant Guided Mount - 3.5 ImplantGlidewell HT Implant Guided Mount - 4.3 ImplantGlidewell HT Implant Guided Mount - 5 ImplantGlidewell HT Implant Guided Pilot Drill - 3 x 8 mmGlidewell HT Implant Guided Pilot Drill - 3.5 - AGlidewell HT Implant Guided Pilot Drill - 3.5 - B | 2013 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Cloudpoint 3D Dental Scannerfastdesign.ioFinalTouchGlidewell Restorative CT | 2015 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Lister | — | 2020 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | Glidewell 3DP Denture Teeth Resin Shade A1Glidewell 3DP Denture Teeth Resin Shade A2Glidewell 3DP Denture Teeth Resin Shade A3Glidewell 3DP Denture Teeth Resin Shade A3.5Glidewell 3DP Denture Teeth Resin Shade A4Glidewell 3DP Denture Teeth Resin Shade B1Glidewell 3DP Denture Teeth Resin Shade B2Glidewell 3DP Denture Teeth Resin Shade B3Glidewell 3DP Denture Teeth Resin Shade BL1Glidewell 3DP Denture Teeth Resin Shade C1 5 moreGlidewell 3DP Denture Teeth Resin Shade C2Glidewell 3DP Denture Teeth Resin Shade C3Glidewell 3DP Denture Teeth Resin Shade C4Glidewell 3DP Denture Teeth Resin Shade D2Glidewell 3DP Denture Teeth Resin Shade D3 | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Prismatik Dentalcraft, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Aug 2026 | K261802 | Glidewell Denture Base Resin | EBI Rebasing Repairing Relining Denture Resin |
| 30 Jul 2026 | K262239 | Obsidian® Press Over Zirconia | EIH Porcelain Powder |
| 30 Jan 2026 | K254283 | BruxZir® Shaded 16 PLUS | EIH Porcelain Powder |
| 18 Nov 2025 | K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | NHA Endosseous Dental Implant Abutment |
| 3 Sep 2025 | K252446 | BruxZir® NOW | EIH Porcelain Powder |
| 25 Jun 2025 | K250302 | Flexible Partial Resin | EBI Rebasing Repairing Relining Denture Resin |
| 25 Feb 2025 | K250223 | BruxZir® Esthetic NOW | EIH Porcelain Powder |
| 12 Sep 2024 | K241493 | Glidewell 3DP Denture Base Resin | EBI Rebasing Repairing Relining Denture Resin |
| 12 Jul 2024 | K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems | NHA Endosseous Dental Implant Abutment |
| 15 May 2024 | K231940 | BruxZir® NOW SRC | NHA Endosseous Dental Implant Abutment |
| 1 May 2024 | K240882 | BruxZir® Esthetic | EIH Porcelain Powder |
| 20 Mar 2024 | K240574 | BruxZir® Radiant | EIH Porcelain Powder |
| 14 Mar 2024 | K231529 | CloudPoint FastDesign Chairside | PNP Dental Abutment Design Software for Dental Laboratory |
| 27 Feb 2024 | K234014 | Obsidian® NOW | EIH Porcelain Powder |
| 14 Nov 2023 | K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG) | LRK Anti-Snoring Device |
| 14 Nov 2023 | K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems | NHA Endosseous Dental Implant Abutment |
| 26 Sep 2023 | K223496 | Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems | NHA Endosseous Dental Implant Abutment |
| 9 Jun 2023 | K231347 | BruxZir TintEFX Coloring Liquid | EIH Porcelain Powder |
| 16 May 2023 | K230262 | BruxZir Incisal Coloring Liquid | EIH Porcelain Powder |
| 2 Aug 2022 | K220816 | BruxZir NOW | EIH Porcelain Powder |
| 29 Jun 2022 | K220960 | BruxZir Opaque Coloring Liquid | EIH Porcelain Powder |
| 22 Jun 2022 | K213765 | Glidewell 3DP Denture Base Resin | EBI Rebasing Repairing Relining Denture Resin |
| 17 Nov 2021 | K213425 | BruxZir Esthetic | EIH Porcelain Powder |
| 26 Oct 2021 | K211069 | EndSnorZ Sleep Appliance | LRK Anti-Snoring Device |
| 16 Jun 2021 | K210694 | Silent Nite Sleep Appliance with the Glidewell Hinge | LRK Anti-Snoring Device |
| 10 Jun 2020 | K200131 | BruxZir Steel | EIH Porcelain Powder |
| 22 Nov 2019 | K191903 | BruxZir GT (Gum Tissue) Color | EIH Porcelain Powder |
| 5 Aug 2019 | K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV | NHA Endosseous Dental Implant Abutment |
| 17 Jul 2019 | K183270 | Silent Nite sl | LRK Anti-Snoring Device |
| 6 Jun 2017 | K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | NHA Endosseous Dental Implant Abutment |
| 16 Nov 2016 | K162537 | CAD/CAMouflage Milling Block | EBF Resin Tooth Shade Material |
| 4 Nov 2016 | K160979 | Inclusive Abutments | NHA Endosseous Dental Implant Abutment |
| 15 Jul 2016 | K160425 | CAD/CAMouflage Milling Bock | EBF Resin Tooth Shade Material |
| 23 May 2016 | K153099 | INCLUSIVE TAPERED IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 16 Nov 2015 | K151798 | Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System | NHA Endosseous Dental Implant Abutment |
| 7 Oct 2015 | K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System | NHA Endosseous Dental Implant Abutment |
| 1 Oct 2015 | K143515 | Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants | NHA Endosseous Dental Implant Abutment |
| 2 Jul 2015 | K150872 | BruxZir Anterior Milling Blanks | EIH Porcelain Powder |
| 2 Apr 2015 | K143353 | Hahn Tapered Implant System | DZE Root-Form Endosseous Implant |
| 6 Jan 2015 | K141923 | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X | NHA Endosseous Dental Implant Abutment |
| 15 Dec 2014 | K143330 | BruxZir Anterior | EIH Porcelain Powder |
| 25 Nov 2014 | K142118 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE | NHA Endosseous Dental Implant Abutment |
| 13 Nov 2014 | K142115 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT | NHA Endosseous Dental Implant Abutment |
| 6 Nov 2014 | K141887 | OBSIDIAN PRESS (ALL CERAMIC AND POM) | EIH Porcelain Powder |
| 22 Oct 2014 | K141211 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS | NHA Endosseous Dental Implant Abutment |
| 20 Aug 2014 | K141788 | OBSIDIAN MILLING BLOCKS | EIH Porcelain Powder |
| 4 Jun 2014 | K133850 | CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) | EBF Resin Tooth Shade Material |
| 12 Sep 2013 | K130604 | UNIVERSAL PASTE STAINS AND GLAZE | EIH Porcelain Powder |
| 16 May 2013 | K130924 | BRUXZIR SHADED | EIH Porcelain Powder |
| 22 Feb 2013 | K121406 | INCLUSIVE TAPERED IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 10 Dec 2012 | K121391 | INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS | NHA Endosseous Dental Implant Abutment |
| 6 Dec 2012 | K120858 | IMPLANT BAR | NHA Endosseous Dental Implant Abutment |
| 12 Oct 2012 | K121688 | MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM | NHA Endosseous Dental Implant Abutment |
| 28 Dec 2010 | K100993 | INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS | NHA Endosseous Dental Implant Abutment |
| 27 Dec 2010 | K100932 | INCLUSIVE MINI IMPLANT | DZE Root-Form Endosseous Implant |
| 21 Jun 2010 | K100781 | OBSIDIAN CERAMIC BLOCKS | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Laboratorios Dentales de Zona Franca, S.A. (13), Young Innovations Inc (11), Sleepcare, LLC (1), IDS Korea (1).
Also lists devices cleared under other names
Prismatik Dentalcraft, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Collagen Matrix, Inc. (3), S & C Polymer GmbH (3), Guilin Woodpecker Medical Instrument Co., Ltd. (2), S&C Polymer Silicon- Und Composite Spezialitaten GmbH (1), Huge Dental Material Co., Ltd. (1), Rizhao Huge Dental Industry Co., Ltd. (1), Rizhao Huge Dental Industry Co., Ltd. (1), Denali Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 6 Jul 2022 | K221033 | UniPrime A, UniPrime E, UniPrime E/C | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | KLE Resin Tooth Bonding Agent |
| 13 Jan 2022 | K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 3 Nov 2020 | K201683 | PMMA Block | Huge Dental Material Co., Ltd. | EBG Resin Temporary Crown and Bridge |
| 9 Feb 2015 | K141421 | PMMA BLOCK | Rizhao Huge Dental Industry Co., Ltd. | EBG Resin Temporary Crown and Bridge |
| 5 Nov 2014 | K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 28 May 2014 | K133071 | ELASTIC IMPRESSION MATERIAL | Rizhao Huge Dental Industry Co., Ltd. | ELW Impression Material |
| 14 Mar 2014 | K132393 | CERCOM II CEMENT | Denali Corporation | EMA Dental Cement |
| 29 Jul 2011 | K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 12 Feb 2009 | K083742 | SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | Collagen Matrix, Inc. | LYC Synthetic Bone Grafting Material |
| 19 Mar 2008 | K080025 | LED.L, LED.M, LED.G, LED.B | Guilin Woodpecker Medical Instrument Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 15 Mar 2006 | K060104 | PRISMATIK CLINICAL ZIRCONIA | Glidewell Laboratories | EIH Porcelain Powder |
| 27 Mar 2003 | K030859 | NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN | Enamelite, LLC | EIH Porcelain Powder |
| 1 Nov 2001 | K012767 | S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL | S & C Polymer GmbH | ELW Impression Material |
| 11 Jun 2001 | K011431 | RESIN CEM | S & C Polymer GmbH | EMA Dental Cement |
| 26 Aug 2000 | K000983 | CERAMIX PORCELAIN SYSTEM | C-Mix | EIH Porcelain Powder |
| 13 Sep 1995 | K953235 | SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3 | The Implant Center of the Palm Beaches | DZE Root-Form Endosseous Implant |
| 31 Mar 1995 | K951075 | S & C VINYL POLYSILOXANE IMPRESSION MATERIAL | S & C Polymer GmbH | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Prismatik Dentalcraft, Inc.FDA reg. 3027248132 | Irvine, CA, United States | Manufacturer |
| PRISMATIK DENTALCRAFT, INC.FDA reg. 3011649314 | Irvine, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043585). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.