HomeGermanyALPHA DENT IMPLANTS GMBH

ALPHA DENT IMPLANTS GMBH

Germany · Pforzheim Baden-Wurttemberg
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 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
3listed device types
Class I 1Class II 2Class III 0
plus 4 registration records and 8 510(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
0active device licences
TWTaiwanTFDA
5valid device licences
Class I 2Class III 3
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 States4 registration records, 8 510(k), 0 PMA, 40 excluded
Brazil0 confirmed, 6 excluded
Canada0 confirmed, 4 excluded
Manufacturer names merged into this page: ALPHA DENT IMPLANTS GMBH
Same-named companies — This database also contains companies with near-identical names: Alpha-Dent. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Germany
City
Pforzheim Baden-Wurttemberg

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

21991 · K904813
11993 · K932827
31994 · K932828
12021 · K210499
12024 · K240435

FDA listed device types

Implant, Endosseous, Root-Form 1Abutment, Implant, Dental, Endosseous 1Accessories, Implant, Dental, Endosseous 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240435Alpha Dent Implants Dental Implants System2024-12-20
USK210499Alpha Dent Implants Dental Implants System2021-11-01
USK932828CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE1994-02-03

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