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Home›United Kingdom of Great Britain and Northern Ireland›PRIMA DENTAL MANUFACTURING TRADING AS PRIMA DENTAL GROUP

PRIMA DENTAL MANUFACTURING TRADING AS PRIMA DENTAL GROUP

United Kingdom of Great Britain and Northern Ireland · Gloucester
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
5listed device types
Class I 5Class II 0Class III 0
plus 5 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class I 6Class II 1
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
5active device licences
Class II 5
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 States5 registration records, 0 510(k), 0 PMA, 5 excluded
Brazil7 confirmed, 3 excluded
Canada5 confirmed, 1 excluded
Manufacturer names merged into this page: PRIMA DENTAL GROUP · PRIMA DENTAL MANUFACTURING TRADING AS PRIMA DENTAL GROUP · Prima Dental · PRIMA DENTAL MANUFACTURING
Same-named companies — This database also contains companies with near-identical names: PRIMA DENTAL GROUP, PRIMA DENTAL MANUFACTURING. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Gloucester

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 listed device types

Bur, Dental 1Mirror, Mouth 1File, Pulp Canal, Endodontic 1Strip, Polishing Agent 1Instrument, Diamond, Dental 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80316910022BROCA ODONTOLÓGICAClass I
BR10347940142BROCAS DE AÇO PRIMA DENTALClass I
BR10347940084ESPELHOS BUCAISClass I
CA75010DENTAL BUR - TUNGSTEN CARBIDEClass II
CA95239PREDATOR ZIRCONIA DIAMOND BURClass II
CA96160DIAMOND BURClass II

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