Manufacturer registered with FDA
Keystone Dental Inc.
Irvine, CA, United States. Lists 12 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 12
- Brands and models
- 122
- 510(k) clearances
- 72007–2024
- Markets registered in
- 5392 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name Keystone Dental 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 | Keystone Dental Inc. | 7 clearances | 2007–2024 | Below |
| Canada | Health Canada | Registration holder | KEYSTONE DENTALKEYSTONE DENTAL, INC. | 328 | 1999–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Keystone Dental, Inc.Keystone Dental, Inc · Keystone Dental, Inc., | 29 | 1999–2013 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | KEYSTONE DENTAL, INC.KEYSTONE DENTAL, INC · Keystone Dental Inc. · +1 | 23 | 2005–2024 | Pure Global AI |
| Colombia | INVIMA | Registration holder | KEYSTONE DENTAL., INC | 12 | — | 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 Keystone Dental 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Arcitexture Surface TechnologyCo AxisCo-Axis ImplantEndosseous Dental Implant SystemGenesis ACTIVEGenesis Implant SystemHA & TPS Restore Self-tapping ImplaHA & TPS Restore Self-Tapping SysteHA-Biontegrated DISMAX-TL Dental Implant System 26 moreModification of RD SingleNSI Hex Non-Hex ParallelNSI Hexed and Non-Hexed Implant SystemO-Ring AbutmentOCT Dental Implant SystemPrima Plus ConicalPrimaConnex Dental Implant SystemPrimaSolo Dental Implant SystemPrimaSolo One-Piece Tapered ImplantsPrimaSoloTemporary/Healing CapsRBM Self-Tapping Threaded Implant WD External Hex Prosthetic Connection 6 x 6.5mmRD Single Stage TPSRestore HA Dental Implant SystemRestore Hex Cylinder DISRestore Self-Tapping Dental ImplantRestore Self-Tapping DISRestore Self-Tapping Implant SystemRestore TPS Dental Implant SystemRestore TPS Hex Cylinder ImplantsSingle Tooth Abutment SystemStage-One Angled Abutment SystemStage-One Single Stage RBMSustain Hex HA Cylinder DISTri-Nex Co AxisTri-Nex Dental Implant SystemZygomatic | 2008 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Genesis ACTIVEGenesis Dental Implant SystemGenesis Implant SystemMAX-TL Dental Implant SystemOCT Dental Implant SystemPrimaConnex Cad/Cam Abutment SystemPrimaConnex Dental Implant SystemPrimaConnex Esthetic Contour Zi AbutmentsRD, UCLA CoCr Sleeve for Hex ImplanStage-One Temporary Healing Cap 4 moreTiLobe Multi-Unit AbutmentsTri-Nex Dental Implant SystemUCLA CoCr Sleeve, RD For PrimaConneUCLA CoCr Sleeve, SD For PrimaConne | 2008 |
| Human Source Bone Grafting MaterialNUN · Class 2 | Bone grafts & membranes | Maker | Accell ConnexusDynaGraftORTHOBLAST II PASTEPUTTY | 2007 |
| Porcelain TeethELL · Class 2 | Dental ceramics & zirconia | Maker | Genesis Dental Implant SystemMAX-TL Dental Implant SystemPrimaConnex Cad/Cam Abutment System | 2008 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | Calforma Calcium Sulfate Bone GraftCalmatrix Calcium Sulfate Bone Graf | 2009 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Bone Profiler w/Guide Pin for External Hex ImplantsBone Profiler with Centering Pin for PrimaConnex ImplantsCountersink Drill for 3.75 Hex ImplantsCountersink Drill for Prima ImplantsCountersink Drill for Renova ImplantsFinishing Drill for Renova ImplantsFull Depth Twist Drill for Genesis ImplantsInitial Drill for Genesis ImplantsInitial Drill for Prima ImplantsInitial Drill for Renova Implants 21 moreIntermediate Drill for Genesis ImplantsIntermediate Drill for Renova ImplantsPilot Drill for Renova ImplantsPilot Drill for Restore ImplantsStep Drill for Prima ImplantsStraight Drill for Genesis ImplantsStraight Drill for Prima ImplantsSurgical Countersink Dril for Stage-1 ImplantsSurgical Tap for External Hex Threaded ImplantsSurgical Tap for Genesis ImplantsSurgical Tap for Prima ImplantsSurgical Tap for Renova ImplantsSurgical Tap for Stage-1 Single Stage Implant SystemTapered Drill for Genesis ImplantsTapered Drill for Prima ImplantsTapered Drill for Renova ImplantsTissue Punch and Guide for Prima ImplantsTri-Spade Drill for Cylinder ImplantsTwist Drill for External Hex Threaded ImplantsTwist Drill for Renova ImplantsTwist Drill for Stage-1 Single Stage Implant System | 2010 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Genesis Implant SystemPrima Dental Implant SystemRENOVA Dental Implant SystemRESTORE Dental Implant SystemSTAGE-1 Dental Implant SystemXP1 Dental Implant System | 2007 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Depth Probe for Prima Implant SystemsRadiographic Depth Gauge for Genesis Implant SystemSurgical Depth Gauge for Renova Implant SystemSurgical Depth Gauge for Stage-1 Single Stage Implant SystemSurgical Depth Probe for External Hex Threaded Implants (Restore) | 2010 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Genesis Implant SystemPrima Dental Implant SystemRENOVA Dental Implant SystemRESTORE Dental Implant SystemSTAGE-1 Dental Implant SystemXP1 Dental Implant System | 2010 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Prima Dental Implant SystemRENOVA Dental Implant SystemRESTORE Dental Implant SystemSTAGE-1 Dental Implant System | 2010 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Genesis Implant SystemPrima Dental Implant SystemRENOVA Dental Implant SystemRESTORE Dental Implant SystemSTAGE-1 Dental Implant SystemXP1 Dental Implant System | 2010 |
| Dental Implant Surgical TrayOFY · Class 1 | Implant instruments & surgical kits | Maker | Genesis Implant SystemPrima Dental Implant SystemRENOVA Dental Implant SystemRESTORE Dental Implant SystemSTAGE-1 Dental Implant System | 2013 |
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 Keystone Dental Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Jul 2024 | K240966 | Prima Plus Conical Implant System | DZE Root-Form Endosseous Implant |
| 25 May 2023 | K223814 | Genesis ACTIVE Implant System | DZE Root-Form Endosseous Implant |
| 10 Aug 2022 | K221381 | KDG Abutments | NHA Endosseous Dental Implant Abutment |
| 18 Aug 2020 | K201334 | Keystone Dental XL Dental Implant System | DZE Root-Form Endosseous Implant |
| 28 Oct 2010 | K101545 | GENESIS IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 5 Jun 2009 | K090397 | XPI ANGLED ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 23 Oct 2007 | K071070 | OLYMPUS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Paltop Advanced Dental Solutions Inc. (1), Smart Denture Conversions, LLC (1).
Also lists devices cleared under other names
Keystone Dental 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: Lifecore Biomedical, Inc. (29), Southern Implants, Inc. (5), Northern Implants, LLC (3), Isotis NV (2), Nsi (2), SeaSpine Orthopedics Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Oct 2010 | K093562 | ENDOSSEOUS DENTAL IMPLANT | Southern Implants, Inc. | DZE Root-Form Endosseous Implant |
| 22 Dec 2008 | K082651 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | DZE Root-Form Endosseous Implant |
| 16 Nov 2007 | K073032 | PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS | Lifecore Biomedical, Inc. | NHA Endosseous Dental Implant Abutment |
| 16 Nov 2007 | K071161 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | DZE Root-Form Endosseous Implant |
| 9 Nov 2007 | K072241 | PRIMACONNEX CAD/CAM ABUTMENT SYSTEM | Lifecore Biomedical, Inc. | NHA Endosseous Dental Implant Abutment |
| 23 Oct 2007 | K072768 | RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 5 Oct 2007 | K072572 | PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS | Lifecore Biomedical, Inc. | NHA Endosseous Dental Implant Abutment |
| 21 Jun 2007 | K070841 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | DZE Root-Form Endosseous Implant |
| 24 May 2007 | K070905 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | DZE Root-Form Endosseous Implant |
| 1 Nov 2006 | K062876 | PRIMACONNEX CERAMIC ABUTMENTS | Lifecore Biomedical, Inc. | NHA Endosseous Dental Implant Abutment |
| 20 Jun 2006 | K061169 | ENDOSSEOUS DENTAL IMPLANT | Northern Implants, LLC | DZE Root-Form Endosseous Implant |
| 22 May 2006 | K060530 | SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. | Lifecore Biomedical, Inc. | ELL Porcelain Teeth |
| 29 Mar 2006 | K060332 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | Isotis NV | NUN Human Source Bone Grafting Material |
| 27 Mar 2006 | K060306 | ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY | Isotis NV | NUN Human Source Bone Grafting Material |
| 23 Jan 2006 | K053643 | STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 | Lifecore Biomedical, Inc. | NHA Endosseous Dental Implant Abutment |
| 8 Dec 2005 | K052490 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Northern Implants, LLC | DZE Root-Form Endosseous Implant |
| 9 Sep 2005 | K051614 | PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 29 Jul 2005 | K043573 | DYNAGRAFT II DENTAL | SeaSpine Orthopedics Corporation | NUN Human Source Bone Grafting Material |
| 15 Apr 2005 | K050506 | PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 14 Feb 2005 | K042730 | CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G | Lifecore Biomedical, Inc. | LYC Synthetic Bone Grafting Material |
| 19 Jul 2004 | K041324 | CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER | Lifecore Biomedical, Inc. | LYC Synthetic Bone Grafting Material |
| 27 Apr 2004 | K033171 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING | Northern Implants, LLC | DZE Root-Form Endosseous Implant |
| 17 Sep 2003 | K032495 | THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 10 May 2002 | K020617 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM | Nsi | DZE Root-Form Endosseous Implant |
| 19 Sep 2001 | K003620 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM | Nsi | DZE Root-Form Endosseous Implant |
| 16 May 2001 | K002037 | LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 12 Jan 2001 | K003226 | THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 8 Mar 2000 | K993894 | LIFECORE SINGLE TOOTH ABUTMENT SYSTEM | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 29 Feb 2000 | K994205 | MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 14 Jul 1999 | K991114 | REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 27 May 1997 | K970776 | LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 28 Mar 1996 | K960288 | HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 23 Feb 1996 | K954512 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 11 Jan 1996 | K954819 | RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 11 Jan 1996 | K954865 | RESTORE HA DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 30 Aug 1995 | K950624 | HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 31 Mar 1995 | K951111 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM) | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 28 Feb 1995 | K944069 | RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 2 Feb 1995 | K944068 | RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM) | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 22 Jul 1994 | K941554 | SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 12 Jul 1994 | K931468 | RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
| 3 Feb 1994 | K914137 | HA-BIONTEGRATED DENTAL IMPLANT SYSTEMS | Lifecore Biomedical, Inc. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Keystone Dental Inc.FDA reg. 3011936113 | Irvine, CA, United States | Complaint file establishment, Manufacturer for export, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9096980). 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.