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Sign in to claim this brandPREMIER DENTAL PRODUCTS COMPANY
United States·US-MF-000015778
Last updated May 27, 2026
What PREMIER DENTAL PRODUCTS COMPANY makes
The company manufactures reusable and single-use dental and respiratory medical devices, including manual endodontic files, dental impression trays, tooth extraction forceps, and dental composites like composite resins and prophy pastes. Their portfolio also includes tracheostomy tubes, decannulation caps, and pelvic-organ-supporting pessaries, as well as specialized dental trays for impression-taking procedures.
The devices fall under FDA Class I and Class II classifications, with some listed as unclassified (U), and are registered in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Premier Dental Products Company manufacture?
Premier Dental Products Company specializes in both reusable and single-use medical devices primarily for dental and respiratory care. Their portfolio includes manual endodontic files and rasps, dental impression trays (single-use), tooth extraction forceps, dental composites like composite resins and prophy pastes, tracheostomy tubes, decannulation caps, and pelvic-organ-supporting pessaries. These devices cater to procedures like root canal treatments, dental impressions, extractions, and respiratory support.
Where is Premier Dental Products Company based?
Premier Dental Products Company is headquartered in the United States. Their location influences their regulatory compliance with U.S. standards, though their devices may also be authorized for use in other regions like the EU, where they are listed in EUDAMED.
Which regulatory registries list Premier Dental Products Company’s devices?
Premier Dental Products Company’s devices are registered in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with regulatory requirements in the European Union and the United States, respectively.
How are Premier Dental Products Company’s devices classified by regulatory authorities?
Premier Dental Products Company’s devices are classified under FDA categories, including Class I (generally low-risk devices) and Class II (devices requiring special controls to ensure safety and effectiveness). Some of their devices are also listed as unclassified (U), meaning they may not fall under standard FDA classification or may be exempt from premarket review. Classification determines the regulatory pathway for authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 1710, ROMANO DR., Plymouth Meeting, United States
- Website
- www.premierdentalco.com
- —
- —
- [email protected]
- Phone
- 6102396069
- PRRC Contact
- Jessica Huang
- EUDAMED SRN
- US-MF-000015778
- FDA FEI Number
- —
- DUNS Number
- 014789663
Catalogue (877)
Page 5 of 18| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Premier Rongeur | 9065076 | FDA UDI | Class I | Active |
| Premier | 1006901 | FDA UDI | Class II | Active |
| Premier K-FILES | 9053238 | FDA UDI | Class I | Active |
| Premier K-FILES | 9053311 | FDA UDI | Class I | Active |
| Premier PEESO drills | 9055021 | FDA UDI | Class I | Active |
| Premier | 1006670 | FDA UDI | Class II | Active |
| Premier REAMERS | 9053033 | FDA UDI | Class I | Active |
| Premier | 8100930 | FDA UDI | Class II | Active |
| Premier | 9006220 | FDA UDI | Class II | Active |
| Premier | 7350152 | FDA UDI | Class II | Active |
| Enamel Pro® Prophy Paste | 9007622 | EUDAMEDFDA UDI | Class I | Active |
| Glitter® Prophy Paste | 9007406 | EUDAMEDFDA UDI | Class I | Active |
| Premier X5 Sectional Matrix System | 9061163 | EUDAMEDFDA UDI | Class I | Active |
| Premier K-FILES | 9053208 | FDA UDI | Class I | Active |
| BioGreen | 3005102 | EUDAMEDFDA UDI | Class I | Active |
| AeroPro Barriers | 5500530 | FDA UDI | Class II | Active |
| Glitter® Prophy Paste | 9007432 | EUDAMEDFDA UDI | Class I | Active |
| Neo Tray | 2206NT | EUDAMEDFDA UDI | Class I | Active |
| Premier | 1034944 | FDA UDI | Class II | Active |
| Premier Plier | 9065085 | FDA UDI | Class I | Active |
| Neo Tray | 2202NT | EUDAMEDFDA UDI | Class I | Active |
| Premier SPRING PASTE FILLER | 9053565 | FDA UDI | Class I | Active |
| Premier | 1050186 | FDA UDI | Class II | Active |
| Premier K-FILES | 9053293 | FDA UDI | Class I | Active |
| RC-Prep | 9007127 | FDA UDI | Class I | Active |
| Enamel Pro® Prophy Paste | 9007627 | EUDAMEDFDA UDI | Class I | Active |
| PIC Plus | 3001551 | FDA UDI | Class II | Active |
| Premier Universal Primer | 3001568 | FDA UDI | Class II | Active |
| Premier | 1006325 | FDA UDI | Class II | Active |
| Premier | 1006063 | FDA UDI | Class II | Active |
| Premier | 1040103 | FDA UDI | Class II | Active |
| Premier | 1050154 | FDA UDI | Class II | Active |
| Premier | 1034318 | FDA UDI | Class II | Active |
| Premier | 3001416 | FDA UDI | Class II | Active |
| Premier H-FILES | 9053434 | FDA UDI | Class I | Active |
| Premier | 1040404 | FDA UDI | Class II | Active |
| Premier | 1040204 | FDA UDI | Class II | Active |
| Premier | 1050190 | FDA UDI | Class II | Active |
| Premier K-FILES | 9053291 | FDA UDI | Class I | Active |
| Sycamore Wood Wedges | 9061100 | FDA UDI | Class I | Active |
| Premier | 1005315 | FDA UDI | Class II | Active |
| Premier | 9006300 | FDA UDI | Class II | Active |
| Accu Bite | 100000027 | EUDAMEDFDA UDI | Class I | Active |
| Premier PEESO drills | 9055024 | FDA UDI | Class I | Active |
| Premier K-FILES | 9053233 | FDA UDI | Class I | Active |
| Comfortview Cushion Refills | 9061382 | FDA UDI | Class I | Active |
| Knit-Pak+ | 9007560 | FDA UDI | U | Active |
| Premier | 1006608 | FDA UDI | Class II | Active |
| Sycamore Wood Wedges | 9061108 | FDA UDI | Class I | Active |
| Premier | 9006297 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (17)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Premier Dental Products Company has 17 recall records listed in the FDA database, with the earliest initiated on April 29, 2004, and the most recent on February 27, 2025. The recalls are marked with statuses including open, classified, and terminated. Reasons provided in the records include instances where dental burs did not meet hardness specifications, potential cryogen leaks from canisters due to seal ring failures, and the presence of foreign objects such as polishing stones in tubes.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 27, 2025 | Z-1408-2025 | — | open, classified | The hardness not meeting the material specification and may cause the diamond bur to bend. |
| Aug 5, 2004 | Z-1468-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Aug 5, 2004 | Z-1467-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Aug 5, 2004 | Z-1470-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Aug 5, 2004 | Z-1463-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Aug 5, 2004 | Z-1466-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Aug 5, 2004 | Z-1471-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Aug 5, 2004 | Z-1460-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Aug 5, 2004 | Z-1464-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Aug 5, 2004 | Z-1459-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Aug 5, 2004 | Z-1469-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Aug 5, 2004 | Z-1462-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Aug 5, 2004 | Z-1461-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Aug 5, 2004 | Z-1465-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Aug 5, 2004 | Z-1458-04 | — | terminated | foreign objects (polishing stones) in the tubes |
| Apr 29, 2004 | Z-0216-05 | — | terminated | Cryogen can escape from canister through the seal ring |
| Apr 29, 2004 | Z-0215-05 | — | terminated | Cryogen can escape from canister through the seal ring |