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Premier Dental

USA · Norristown
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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
Same-named companies — This database also contains companies with near-identical names: Premier Dental Products Company. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Norristown

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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)

MarketIdentifierNameClass / date
USK260682Bond-PR™ Universal Adhesive2026-03-03
USK253513MultiMatch Flow Chameleon AntiMicrobial Composite2025-11-07
USK223632Premier's MultiMatch Universal Chameleon Restorative Composite2022-12-06
CA71816FG CARBIDE DENTAL BURSClass II
CA71817DRILLSClass II
CA71819POLI-PRO POLISHING SYSTEMClass II

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