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Home›Austria›Amann Girrbach AG

Amann Girrbach AG

Austria · Maeder
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 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
20listed device types
Class I 12Class II 7Class III 0unclassified 1
plus 36 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
18registered devices
Class I 4Class II 14
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
7registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
5 including historic records
TWTaiwanTFDA
11valid device licences
Class I 4Class II 7
SGSingaporeHSA SMDR
9device registrations
CLASS B 9
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
5active ARTG entries
IIa 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
17active registrations
Class 1 11Class 2a 6
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 States36 registration records, 5 510(k), 0 PMA
Brazil18 confirmed, 0 excluded
Saudi Arabia7 confirmed, 0 excluded
Manufacturer names merged into this page: Amann Girrbach AG · Amann Girrbach North America, LP · AMANN GIRRBACH AG
Same-named companies — This database also contains companies with near-identical names: Amann Girrbach America, Inc., Amann Girrbach North America, LP. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Austria
City
Maeder

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

12007 · K063511
12017 · K171876
22019 · K191836
12026 · K260918

FDA listed device types

showing 8 of 20
Resin, Denture, Relining, Repairing, Rebasing 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Alloy, Metal, Base 1Crown And Bridge, Temporary, Resin 1Material, Tooth Shade, Resin 1Powder, Porcelain 1Crown And Bridge, Long-Term Temporary, Resin 1Mouthguard, Prescription 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260918Zolid Lunaris2026-06-29
USK191836Ceramill A-Splint2019-12-20
USK191843Ceramill A-Temp2019-10-04
BR10344420170KIT DE POLIMENTO PARA DENTISTAClass I
BR80117589166Zolid LunarisClass II
BR80117580369CERAMILL SINTRONClass II
SAME0000000610SFDAA00002Ceramill Map 200+—
SAME0000000610SFDAA00003Ceramill Map 400+—

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