Medical Device Manufacturer · AT , Buermoos

W&H Dentalwerk Buermoos GmbH - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 1999

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

FDA 510(k) Regulatory Record - W&H Dentalwerk Buermoos GmbH Dental ✕

17 devices

1-12 of 17

Cleared Jun 18, 2026

Implantmed Plus II & Piezomed Plus II Module

Cleared Feb 24, 2021

PROXEO Twist Cordless Polishing System PL-40 H

Cleared Mar 26, 2019

Electric Handpiece Motor

Cleared Dec 08, 2017

W&H Assistina Twin

Cleared Nov 23, 2015

Advanced Air System

Cleared Oct 16, 2014

Cleared Jul 09, 2010

PROSTHODONTIC SCREWDRIVER , MODEL IA-400

Cleared Jan 14, 2010

W&H HANDPIECE ANESTO, MODEL: RA-5

Cleared Dec 15, 2009

CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR

Cleared Jun 30, 2009

CONTRA-ANGLE HANDPIECE KOMET OS30

Cleared Jul 29, 2008

SURGICAL HANDPIECES, MIKRO SAW HANDPIECES

Cleared May 03, 2006

DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM