Manufacturer registered with FDA
Premier Dental Products Company
Plymouth Meeting, PA, United States. Lists 64 dental device types with FDA across 2 registered establishments, and holds 28 510(k) clearances as applicant.
- Device types listed
- 64
- Brands and models
- 119
- 510(k) clearances
- 281977–2026
- Markets registered in
- 544 registrations outside the US
- Establishments
- 2United States
510(k) clearances per year, 1976–2026
Registered in 5 markets
Where regulators' registries name Premier Dental Products Company 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 | Premier Dental Products Company | 28 clearances | 1977–2026 | Below |
| Taiwan | TFDA | Manufacturer | PREMIER DENTAL PRODUCTS COMPANYPREMIER DENTAL PRODUCTS CO. | 19 | 2005–2024 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | PREMIER DENTAL PRODUCTS COMPANY, INC.PREMIER DENTAL PRODUCTS CO. · PREMIER DENTAL PRODUCTS COMPANY | 13 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Premier Dental Products CompanyPremier Dental Products Company, Inc | 10 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | PREMIER DENTAL PRODUCTS CO. | 2 | 2017–2026 | 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 Premier Dental Products Company 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 | CompCore AFMultiMatchMultiMatch Flow Chameleon AntiMicrobial CompositePremier IntegraBond | 2007 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | BOND BOOST SEBond-PRPremier Ceramic PrimerPremier Spot-On Etch | 2006 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Premier Implant CementPREMIER TEMPORARY CEMENTZR-Cem | 2004 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | Bond-PRENAMEL PRO VARNISHTastyTooth Varnish | 2006 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Premier Dental Products Company | 2019 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | BioCoatMultiMatch Flow Chameleon AntiMicrobial Composite | 2016 |
| Anesthetic Tube WarmerEFC · Class 1 | — | Maker | Premier Cartridge Warmer | 1977 |
| Roll CottonEFN · Class 1 | — | Maker | Premier Retraction Caps | 2009 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | Premier Poli-Pro polishing System | 2005 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | AccuBiteAlfaBite-TrayEmulateFirst BiteMaxima TrayNeoTrayNice BitePremierPremier® Triple Tray® 3 moreQualaT-LOC Triple TrayZhermack | 1980 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | PREMIER RETRACTORS | 2002 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | PREMIER WAX CARVER | 2002 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | PREMIER DEPTH GAUGE | 2002 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | Premier | 1977 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | PERIOWISE PERIODONTAL PROBE | 1996 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | PREMIER PLASTIC FILLIN | 1991 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | PREMIER INSTRUMENT HANDLE | 2002 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | Diamond Twist SCLDiamond Twist SCO | 2023 |
| Operative Margin Finishing KnifeEJZ · Class 1 | Dental hand instruments | Maker | PREMIER KNIVES | 2002 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | PREMIER EXPLORER | 2002 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | PREMIER EXCAVATOR | 2002 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | Black Cutting HatchetBlack Cutting InstrumentCalif Cutting Instrument | 2002 |
| Operative Amalgam and Foil CondenserEKG · Class 1 | Dental hand instruments | Maker | PREMIER AMALGAM CONDENSER | 2002 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | PREMIER AMALGAM CARVER | 2002 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | AMALGAM | 1977 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | PREMIER OPERATIVE BURNISHER | 2002 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Premier Endodontic Spreaders | 1993 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Premier Endodontic Pluggers | 1993 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Maker | PREMIER SCALERS | 2002 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Premier Ultrasonic Scaler | 2008 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | PREMIER BONE FILE | 2002 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | PREMIER SURGICAL ELEVATOR | 2002 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | PREMIER SURGICAL CURETTE | 2002 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Premier | 2009 |
| Periodontic KnifeEMO · Class 1 | Dental hand instruments | Maker | PREMIER PERIODONTIC KNIVES | 2002 |
| Periodontic FileEMR · Class 1 | Dental hand instruments | Maker | PREMIER PERIODONTIC FILE | 2002 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | PREMIER PERIODONTIC CURETTE | 2002 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Cure-ThruPremier X5 Essential Kit- No InstrumentsPremier X5 ForcepsPremier X5 Intro KitPremier X5 Matrix Pin HolderPremier X5 Matrix Refill 3.5 mm -Qty 25Premier X5 Matrix Refill 4.5 mm -Qty 80Premier X5 Matrix Refill 5.5 mm -Qty 80Premier X5 Matrix Refill 6.5 mm -Qty 80Premier X5 Ring Universal- Qty 35 6 morePremier X5 Sample PackPremier X5 Wedge Large Blue-Qty 100Premier X5 Wedge Medium Green-Qty 100Premier X5 Wedge Small Yellow-Qty 100Sycamore Wood WedgesVeneerNow | 1977 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Maker | MultiMatch Flow Chameleon AntiMicrobial Composite | 2025 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | INTEGRA POST DRILLS | 2002 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | SOLO DIAMOND | 1977 |
| Articulation Paper ForcepsEFK · Class 1 | Dental hand instruments | Maker | Premier® Forceps - Articulation Paper | 1977 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Lister | Premier | 1977 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Premier® 2pro® Disposable Prophy AnglePremier® ProFlare Disposable Prophy Angle | 2009 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Denmat Ceri-Sander | 2023 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | BiocoatCompCore AFItenaMICRODOSE SYRINGEMix-TipsMultiMatchMultiMatch FlowNexTempRC-PrepTraxodent | 2002 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Lister | AND CROWNCOLLAR | 1977 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Lister | FORCEPSRUBBER DAM CLAMP | 1977 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | DENTAL ARTICULATORSW.O.W. | 2006 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Diamond PasteEnamel Pro Prophy Paste | 1999 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Lister | DENTAL PLIERS | 1977 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Premier Absorbent Points | 2023 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | RC PREP | 1993 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | AeroPro Cordless Prophy System | 2019 |
| Porcelain TeethELL · Class 2 | Dental ceramics & zirconia | Maker | Porcelain Silane | 2010 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | INTEGRA POST | 1998 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Lister | HEMOSTAT | 1977 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Lister | FORCEPS | 1977 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Lister | FORCEPS | 1977 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | Premier | 2002 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | PREMIER OSTEOTOME CHISEL | 2002 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Izzo | 2021 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Maker | Pro Clean | 2022 |
| Resin ApplicatorKXR · Class 1 | — | Maker | BioGreen Biodegradable Micro-Applicators | 2021 |
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 Premier Dental Products Company as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Mar 2026 | K260682 | Bond-PR Universal Adhesive | KLE Resin Tooth Bonding Agent |
| 7 Nov 2025 | K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | EBF Resin Tooth Shade Material |
| 6 Dec 2022 | K223632 | Premier's MultiMatch Universal Chameleon Restorative Composite | EBF Resin Tooth Shade Material |
| 17 Nov 2014 | K141839 | PREMIER ETCH | KLE Resin Tooth Bonding Agent |
| 26 Aug 2013 | K131212 | PREMIER CERAMIC PRIMER | KLE Resin Tooth Bonding Agent |
| 21 Nov 2006 | K062683 | ENAMEL PRO VARNISH | LBH Cavity Varnish |
| 21 Nov 2006 | K062166 | ENAMEL PRO | EJR Oral Cavity Abrasive Polishing Agent |
| 4 Oct 2006 | K061998 | PREMIER SELF-ETCHING BOND ENHANCER | KLE Resin Tooth Bonding Agent |
| 4 Oct 2006 | K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT | EBC Pit and Fissure Sealant and Conditioner |
| 6 Sep 2005 | K051866 | PREMIER TEMPORARY CEMENT | EMA Dental Cement |
| 21 Sep 2004 | K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | EMA Dental Cement |
| 26 Jan 2004 | K033309 | PREMIER IMPLANT CEMENT, MODEL 3001450 | EMA Dental Cement |
| 27 Sep 2001 | K012160 | COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 | EBF Resin Tooth Shade Material |
| 17 Apr 2001 | K010195 | PREMIER ULTRASONIC SCALER AND INSERTS | ELC Ultrasonic Scaler |
| 24 Jun 1991 | K912149 | HARDCOATED PLASTIC FILLING INSTRUMENT | EKJ Operative Burnisher |
| 9 Jun 1989 | K891536 | ENAMEL MICROABRASION COMPOUND | EJR Oral Cavity Abrasive Polishing Agent |
| 14 Nov 1988 | K884418 | PREMIER DIE-TRAK ARTICULATOR | EJP Articulators |
| 15 Jun 1984 | K841011 | ELEVATOR - VARIOUS | EMS Periodontic Curette |
| 29 Apr 1980 | K800900 | PREMIER TRIPLE TRAY | EHY Preformed Impression Tray |
| 29 Apr 1980 | K800827 | PREMIER ABSORBENT POINTS | EKN Endodontic Paper Point |
| 2 Mar 1979 | K790325 | REPRODENT | EBI Rebasing Repairing Relining Denture Resin |
| 21 Feb 1979 | K782139 | ZYLOX | ELW Impression Material |
| 30 Jun 1978 | K781035 | PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX | EMN Periodontic Scaler |
| 30 Jun 1978 | K781034 | PREMIER INLAY PLACER | EKI Operative Amalgam Carrier |
| 22 Jun 1978 | K780796 | ZYTRON | EBF Resin Tooth Shade Material |
| 19 Apr 1978 | K780528 | PREMIER CARVERS, STYLE #21C & 21D | EKH Operative Dental Amalgam Carver |
| 16 Aug 1977 | K771522 | FORCEPS, STYLE #849 | EMH Surgical Rongeur Forceps |
| 16 Aug 1977 | K771451 | SCUTABOND | EMA Dental Cement |
Some of these clearances are listed with FDA today by another company: B.J.M. Laboratories Ltd (11), Solventum US LLC (1).
Also lists devices cleared under other names
Premier Dental Products Company 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: Premier Dental Company Products (3), Medical Products Laboratories, Inc. (1), Silmet U.S.A. Corp. (1), Unicep (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Feb 2019 | K180682 | AeroPro Cordless Prophy System | Premier Dental Company Products | EKX Ac-Powered Direct Drive Handpiece |
| 18 Oct 2016 | K161580 | Premier Sealant | Premier Dental Company Products | EBC Pit and Fissure Sealant and Conditioner |
| 22 Jul 2015 | K150601 | Zeramic Adhesive Resin Cement | Premier Dental Company Products | EMA Dental Cement |
| 4 Feb 2004 | K040098 | VARNISHAMERICA | Medical Products Laboratories, Inc. | LBH Cavity Varnish |
| 26 Jan 1994 | K933766 | HIGH-Q-BOND | Silmet U.S.A. Corp. | EBF Resin Tooth Shade Material |
| 16 Mar 1993 | K924823 | MICRODOSE SILANE | Unicep | ELL Porcelain Teeth |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PREMIER DENTAL PRODUCTS CO.FDA reg. 2511556 | PLYMOUTH MEETING, PA, United States | Complaint file establishment, Repacker / relabeler, Specification developer |
| PREMIER MEDICALFDA reg. 2521453 | PHILADELPHIA, PA, United States | Contract manufacturer, Repacker / relabeler |
Other names on FDA records
Premier Medical
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2511556). 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.