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Premier Dental Products Company

USA · Plymouth Meeting

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

101listed device types

Class I 82Class II 17Class III 0unclassified 2

plus 114 registration records and 48 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

10active device licences

Class II 7Class III 3

32 including historic records

TWTaiwanTFDA

5valid device licences

Class I 4Class II 1

SGSingaporeHSA SMDR

6device registrations

CLASS B 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

74active ARTG entries

Class I 56IIa 18

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States114 registration records, 48 510(k), 0 PMA, 30 excluded

Brazil0 confirmed, 2 excluded

Canada10 confirmed, 1 excluded

Manufacturer names merged into this page: PREMIER DENTAL PRODUCTS CO. · PREMIER DENTAL PRODUCTS COMPANY

FDA 510(k) clearances by year

121984

11988

11989

11991

11992

21995

11997

22001

22004

12005

42006

12009

22013

12014

12015

12016

12019

12022

12025

12026

FDA listed device types

showing 8 of 101

Knife, Margin Finishing, Operative 1Syringe, Restorative And Impression Material 1Drill, Dental, Intraoral 1Disk, Abrasive 1Strip, Polishing Agent 1Sound, Uterine 1Instrument, Filling, Plastic, Dental 1Pliers, Operative 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260682	Bond-PR Universal Adhesive	2026-03-03
US	K253513	MultiMatch Flow Chameleon AntiMicrobial Composite	2025-11-07
US	K223632	Premier's MultiMatch Universal Chameleon Restorative Composite	2022-12-06
CA	71816	FG CARBIDE DENTAL BURS	Class II
CA	71817	DRILLS	Class II
CA	71819	POLI-PRO POLISHING SYSTEM	Class II

Premier Dental Products Company

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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