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

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
1-18 of 18
Cleared Jun 18, 2026
Implantmed Plus II & Piezomed Plus II Module
K253776 · DZI
Dental · 204d
Cleared Jul 03, 2025
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed...
K243280 · ERL
Ear, Nose, Throat · 259d
Cleared Feb 24, 2021
PROXEO Twist Cordless Polishing System PL-40 H
K201703 · EKX
Dental · 247d
Cleared Mar 26, 2019
Electric Handpiece Motor
K181858 · EBW
Dental · 257d
Cleared Dec 08, 2017
W&H Assistina Twin
K171553 · EFB
Dental · 192d
Cleared Nov 23, 2015
Advanced Air System
K143704 · EFB
Dental · 329d
Cleared Oct 16, 2014
PIEZOMED
K133488 · DZI
Dental · 337d
Cleared Jul 09, 2010
PROSTHODONTIC SCREWDRIVER , MODEL IA-400
K100600 · EKX
Dental · 128d
Cleared Jan 14, 2010
W&H HANDPIECE ANESTO, MODEL: RA-5
K083811 · EGM
Dental · 388d
Cleared Dec 15, 2009
CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR
K090931 · EKX
Dental · 257d
Cleared Jun 30, 2009
CONTRA-ANGLE HANDPIECE KOMET OS30
K090548 · EFB
Dental · 120d
Cleared Jul 29, 2008
SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
K080939 · KMW
Dental · 117d
Cleared May 03, 2006
DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
K060287 · EBW
Dental · 86d
Cleared Jan 13, 2006
IMPLANTMED SI-915 (115V VERSION)
K052741 · EBW
Dental · 105d
Cleared May 03, 2002
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
K014068 · EBW
Dental · 144d
Cleared Jun 28, 2001
SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL...
K011061 · EGS
Dental · 83d
Cleared Feb 07, 2001
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
K002469 · EBW
Dental · 180d
Cleared Jun 25, 1999
SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988...
K984508 · DZA
Dental · 189d
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