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PREMIER 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 6102396069
PRRC Contact: Jessica Huang
EUDAMED SRN: US-MF-000015778
FDA FEI Number: —
DUNS Number: 014789663

Catalogue (877)

Page 3 of 18

Device	Model / Reference	Registries	Class	Status
Hemodent	9007073	FDA UDI	U	Active
Premier H-FILES	9053400	FDA UDI	Class I	Active
Premier	1034965	FDA UDI	Class II	Active
Premier	1034943	FDA UDI	Class II	Active
Premier PLUGGERS	9053794	FDA UDI	Class I	Active
Premier	1037833	FDA UDI	Class II	Active
Premier	7350154	FDA UDI	Class II	Active
Premier PEESO drills	9055023	FDA UDI	Class I	Active
Premier	1040114	FDA UDI	Class II	Active
Premier	1005300	FDA UDI	Class II	Active
Premier	9006215	FDA UDI	Class II	Active
Premier	1034967	FDA UDI	Class II	Active
Premier REAMERS	9053003	FDA UDI	Class I	Active
Premier	8100900	FDA UDI	Class II	Active
Premier® Absorbent Points	9055105	FDA UDI	Class I	Active
Premier	1010111	FDA UDI	Class II	Active
Coated Graves Specula	9086501	FDA UDI	Class I	Active
Premier Total Etch	3001422	FDA UDI	Class II	Active
Premier	1034618	FDA UDI	Class II	Active
Premier	1006640	FDA UDI	Class II	Active
Premier	3001491	FDA UDI	Class II	Active
Premier	9006130	FDA UDI	Class II	Active
Premier	1050160	FDA UDI	Class II	Active
Premier	1040119	FDA UDI	Class II	Active
Premier	9007543	FDA UDI	Class II	Unknown
Premier	1050188	FDA UDI	Class II	Active
Premier Forceps	9065063	FDA UDI	Class I	Active
Enamel Pro® Prophy Paste	9007618	EUDAMEDFDA UDI	Class I	Active
CompCORE AF	3001512	FDA UDI	Class II	Active
Premier	1034614	FDA UDI	Class II	Active
Vac Attak™	9011912	EUDAMEDFDA UDI	Class I	Active
Premier	8100933	FDA UDI	Class II	Active
ProFlare	5500150	FDA UDI	Class I	Active
Premier	9007544	FDA UDI	Class II	Unknown
Premier	1040304	FDA UDI	Class II	Active
Premier SPREADERS	9053842	FDA UDI	Class I	Active
2pro	5510001	FDA UDI	Class I	Active
Premier	9007533	FDA UDI	Class II	Active
Premier	1006800	FDA UDI	Class II	Active
Premier REAMERS	9053036	FDA UDI	Class I	Active
Enamel Pro® Prophy Paste	9007605	EUDAMEDFDA UDI	Class I	Active
Vac Attak™ Green	9011995	EUDAMEDFDA UDI	Class I	Active
Premier Forceps	9065009	FDA UDI	Class I	Active
Premier K-FILES	9053290	FDA UDI	Class I	Active
BioGreen	3005101	EUDAMEDFDA UDI	Class I	Active
BioGreen	3005100	EUDAMEDFDA UDI	Class I	Active
Premier	1034610	FDA UDI	Class II	Active
Premier Serrated Forceps	9065078	FDA UDI	Class I	Active
Knit-Pak	9007552	EUDAMEDFDA UDI	U	Active
2pro	5510004	FDA UDI	Class I	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