W&H Dentalwerk Buermoos GmbH is one of 30 FDA 510(k) medical device manufacturers from Austria in the dataset, ranked by real submission volume.
W&H Dentalwerk Buermoos GmbH - FDA 510(k) Cleared Devices
Recent clearances: Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories), PROXEO Twist Cordless Polishing System PL-40 H, Electric Handpiece Motor
18
Total
18
Cleared
0
Denied
W&H Dentalwerk Buermoos GmbH has 18 FDA 510(k) cleared dental devices. Based in Buermoos, AT.
Latest FDA clearance: Jun 2026. Active since 1999.
Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - W&H Dentalwerk Buermoos GmbH
18 devices
Cleared
Jun 18, 2026
Implantmed Plus II & Piezomed Plus II Module
Dental
204d
Cleared
Jul 03, 2025
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed...
Ear, Nose, Throat
259d
Cleared
Feb 24, 2021
PROXEO Twist Cordless Polishing System PL-40 H
Dental
247d
Cleared
Mar 26, 2019
Electric Handpiece Motor
Dental
257d
Cleared
Dec 08, 2017
W&H Assistina Twin
Dental
192d
Cleared
Nov 23, 2015
Advanced Air System
Dental
329d
Cleared
Oct 16, 2014
PIEZOMED
Dental
337d
Cleared
Jul 09, 2010
PROSTHODONTIC SCREWDRIVER , MODEL IA-400
Dental
128d
Cleared
Jan 14, 2010
W&H HANDPIECE ANESTO, MODEL: RA-5
Dental
388d
Cleared
Dec 15, 2009
CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR
Dental
257d
Cleared
Jun 30, 2009
CONTRA-ANGLE HANDPIECE KOMET OS30
Dental
120d
Cleared
Jul 29, 2008
SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
Dental
117d