Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003444492

FEI Number

3003444492

Entity Name

PRIMA DENTAL GROUP

City/State/Country

GLOUCESTER Gloucestershire, GB

Establishment Address

STEPHENSON DRIVE, GLOUCESTER Gloucestershire GL2 2HA, GB

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Prima Dental Group (Owner Number: 9028341)

Owner / Operator Contact Address

Stephenson Drive, GLOUCESTER, ENGLAND, GB-GLS GL2 2HA, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Predator Zirconia Diamonds Prima Classic Diamonds Prima Taper Prima One Gold Prima Taper Gold Prima Dental Illume Polisher, Dental

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2017-11-04
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2019-11-08
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2015-05-01

Official Correspondent

Ruth Clancy

US Agent Details

Liz Meyers Business: Darby Dental Supply LLC Email: Liz.Meyers@DarbyDentalSupply.com Phone: (516) 6886410

Related Public Records

Same Entity

Prima Dental Group

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

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8030938	DIRECTA AB	UPPLANDS VAESBY Stockholm, SE
9615845	RECO-DENT INTL. CO., LTD.	NEW TAIPEI CITY, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003444492. Last updated year: 2026. Please use registration number 3003444492 when referencing this establishment in official correspondence.