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Home›Austria›W&H DENTALWERK BUERMOOS GMBH

W&H DENTALWERK BUERMOOS GMBH

Austria · Buermoos Salzburg
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Russia — 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
27listed device types
Class I 18Class II 8Class III 0unclassified 1
plus 104 registration records and 20 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
10registered devices
Class I 2Class II 8
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
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
3active registrations
Class 1 2Class 2a 1
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 States104 registration records, 20 510(k), 0 PMA
Brazil10 confirmed, 0 excluded
Manufacturer names merged into this page: W&H DENTALWERK BUERMOOS GMBH - SITE 2 · W&H DENTALWERK BUERMOOS GMBH · W&H DENTALWERK BÜRMOOS GMBH
Same-named companies — This database also contains companies with near-identical names: W&H DENTALWERK BUERMOOS GMBH - SITE 2. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Austria
City
Buermoos Salzburg

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

11999
22001
12002
22006
12008
22009
22010
12014
12015
12017
12019
12021
22025
22026

FDA listed device types

showing 8 of 27
Motor, Surgical Instrument, Ac-Powered 1Controller, Foot, Handpiece And Cord 1Handpiece, Direct Drive, Ac-Powered 1Handpiece, Contra- And Right-Angle Attachment, Dental 1Handpiece, Air-Powered, Dental 1Unit, Operative Dental 1Bur, Surgical, General & Plastic Surgery 1Plugger, Root Canal, Endodontic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253655Angled Screwdriver MED (M-SD090)2026-07-31
USK253776Implantmed Plus II & Piezomed Plus II Module2026-06-18
USK243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)2025-07-03
BR10347940153Pontas CirúrgicasClass I
BR10347940138IMPLANTMEDClass II
BR80047309241Piezomed ProClass II

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