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Home›USA›Instrumentarium Dental, Inc.

Instrumentarium Dental, Inc.

USA · Milwaukee
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Singapore — 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
6510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 6 510(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 10
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
3device registrations
CLASS B 1CLASS C 2
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 States0 registration records, 6 510(k), 0 PMA, 9 excluded
Canada10 confirmed, 1 excluded
Manufacturer names merged into this page: PALODEX GROUP OY ALSO TRADING AS INSTRUMENTARIUM DENTAL
Same-named companies — This database also contains companies with near-identical names: Instrumentarium Dental, Palodex Group OY. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Milwaukee

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

22007 · K063837
12008 · K081925
12009 · K092591
12010 · K093683
12014 · K133231

Registration details (sample)

MarketIdentifierNameClass / date
USK133231DIGORA OPTIME2014-03-20
USK093683ORTHOPANTOMOGRAPH OP3002010-10-06
USK092591ORTHOPANTOMOGRAPH OP302009-11-20
CA36653SIGMAClass II
CA36654ORTHOPANTOMOGRAPH OP100DClass II
CA36919ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 (EXTRAORAL DENTAL X-RAY SYSTEMS)Class II

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