Manufacturer registered with FDA
Prime Dental Manufacturing, Inc.
Chicago, IL, United States. Lists 16 dental device types with FDA across 1 registered establishment, and holds 9 510(k) clearances as applicant.
- Device types listed
- 16
- Brands and models
- 74
- 510(k) clearances
- 92000–2012
- Markets registered in
- 6124 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 6 markets
Where regulators' registries name Prime Dental Manufacturing, 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 | Prime Dental Manufacturing, Inc. | 9 clearances | 2000–2012 | Below |
| Colombia | INVIMA | Manufacturer | PRIME DENTAL MANUFACTURING INC.PRIME DENTAL MANUFACTURING, INC. · PRIME DENTAL MANUFACTURING, INC · +1 | 94 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PRIME DENTAL MANUFACTURING INC.PRIME DENTAL MANUFACTURING, INC. · PRIME DENTAL MANUFACTURING, INC | 15 | 2005–2023 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | PRIME DENTAL MANUFACTURING, INCPRIME DENTAL MANUFACTURING INC | 9 | 2019–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Prime Dental Manufacturing IncPrime Dental Manufacturing Inc. · Prime Dental Manufacturing, Inc. | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Prime Dental Manufacturing Inc. | 2 | 2015–2016 | 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 Prime Dental Manufacturing, 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 |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Prime-CorePrime-Dent Automix Dual Cure Core Build Up MaterialPrime-Dent Chemical Core Build Up MaterialPrime-Dent Chemical Cure Composite Restorative MaterialPrime-Dent Chemical Cure Dentin/Enamel Bonding AdhesivePrime-Dent Citric AcidPrime-Dent Etchant GelPrime-Dent Etchant LiquidPrime-Dent Hema DesensitizerPrime-Dent Light Cure Core Build Up Material 21 morePrime-Dent Light Cure Dentin/Enamel Bonding AdhesivePrime-Dent Light Cure One Step Dentin/Enamel Bonding AdhesivePrime-Dent ParafilPrime-Dent Parafil GingivaPrime-Dent Parafil LABPrime-Dent Parafil ModelerPrime-Dent Parafil ModifierPrime-Dent Parafil PrimerPrime-Dent Parafil SeparatorPrime-Dent Parafil StainsPrime-Dent Porcelain Etchant GelPrime-Dent Porcelain Repair KitPrime-Dent Self Etch Bonding AgentPrime-Dent Silane Bond EnhancerPrime-Dent Surface SealantPrime-Dent Visible Chemical Cure Pit and FissurePrime-Dent Visible Light Cure Composite Restorative MaterialPrime-Dent Visible Light Cure Flowable CompositePrime-Dent Visible Light Cure Hybrid CompositePrime-Dent Visible Light Cure Micro-Hybrid CompositePrime-Dent Visible Light Cure Nano-Hybrid Composite | 1999 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Maker | Prime-Dent Dual Cure Glass Ionomer Band CementPrime-Dent Light Cure Glass Ionomer Band CementPrime-Dent MegasetPrime-Dent One Step Orthodontic AdhesivePrime-Dent Visible Light Cure Orthodontic Adhesive | 2013 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Dental DamLight Cure Soft Dental DamPrime Blend UltraPrime-Paste | 2004 |
| Intraoral X-Ray UnitEAP · Class 2 | Dental X-ray units | Maker | — | 2026 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | Prime-Dent Visible Light Cure Pit and Fissure | 2013 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Prime-Dent Alginate FlavoringPrime-Dent Tray Adhesive | 2019 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | Top Cahin - LongTop Chain - ContinuesTop Chain - MinisTop SticksTop Sticks - Minis | 2017 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | APIG Pressure Indicating Gel | 2016 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | Prime-Dent Root Canal Filling MaterialRC-CREAM | 2017 |
| Preformed CrownELZ · Class 1 | — | Maker | Prime-Crown | 2017 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Prime-Dent Automix Dual Cure Luting CementPrime-Dent Dual Cure Luting CementPrime-Dent Glass Ionomer CementPrime-Dent Glass Ionomer Light Cured RestorativePrime-Dent Glass Ionomer RestorativePrime-Dent Non Eugenol Temporary CementPrime-Dent Temporary CementPrime-Dent Visible Light Cure Luting Cement | 2013 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | Prime Dent Zinc Oxide Eugenol CementPrime Dent Zinc Oxide Eugenol Reinforced CementPrime Dent Zinc Phosphate Cement | 2022 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Prime-Dent Chemical Cure Composite Restorative MaterialPrime-Dent Chemical Cure Dentin/Enamel Bonding Adhesive | 2013 |
| Resin ApplicatorKXR · Class 1 | — | Maker | — | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Prime-Crown Mixing TipsPrime-Dent Brush HolderPrime-Dent Long BrushesPrime-Dent Luer Lock Dispensing Needle TipsPrime-Dent Mixing PadsPrime-Dent Mixing SpatulasPrime-Dent Mixing TipsPrime-Dent Short Shank Brushes | 2017 |
| External Cleaning SolutionPME · Class 2 | — | Maker | Prime-Dent White Fluoride Varnish | 2019 |
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 Prime Dental Manufacturing, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Jan 2012 | K112574 | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT | EMA Dental Cement |
| 7 Nov 2002 | K022675 | PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL | EBF Resin Tooth Shade Material |
| 19 Jul 2002 | K021524 | LIGHT CURE DENTAL DAM | EIE Rubber Dam |
| 19 Feb 2002 | K013970 | PRIME-DENT HEMA DESENSITIZER | EBF Resin Tooth Shade Material |
| 5 Nov 2001 | K012794 | PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT | EBF Resin Tooth Shade Material |
| 1 Nov 2001 | K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | EBC Pit and Fissure Sealant and Conditioner |
| 24 Oct 2001 | K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 30 May 2000 | K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | EBF Resin Tooth Shade Material |
| 31 Jan 2000 | K994224 | PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: Viarden Lab LLC (5), 3D Dental Designs and Development LLC (4), Pac-Dent Inc. (1), O&S Dental Inc (1), Young Innovations Inc (1), World Class Technology Corporation (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PRIME DENTAL MANUFACTURING, INC.FDA reg. 1424442 | CHICAGO, IL, United States | Contract manufacturer, Manufacturer for export, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9039081). 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.