Medical Device Manufacturer · AT , Buermoos

W&H Dentalwerk Buermoos GmbH

17 submissions · 17 cleared · Since 1999
17
Total
17
Cleared
0
Denied

W&H Dentalwerk Buermoos GmbH — FDA 510(k) Submissions

W&H Dentalwerk Buermoos GmbH has submitted 17 FDA 510(k) premarket notifications since 1999, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Controller, Foot, Handpiece And Cord, Handpiece, Air-powered, Dental, Handpiece, Direct Drive, Ac-powered, Drill, Bone, Powered, Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
K243280 · ERL Drill, Surgical, Ent... · Ear, Nose, Throat
Jul 2025 259d
PROXEO Twist Cordless Polishing System PL-40 H
K201703 · EKX Handpiece, Direct Drive,... · Dental
Feb 2021 247d
Electric Handpiece Motor
K181858 · EBW Controller, Foot,... · Dental
Mar 2019 257d
W&H Assistina Twin
K171553 · EFB Handpiece, Air-powered,... · Dental
Dec 2017 192d
Advanced Air System
K143704 · EFB Handpiece, Air-powered,... · Dental
Nov 2015 329d
PIEZOMED
K133488 · DZI Drill, Bone, Powered · Dental
Oct 2014 337d
PROSTHODONTIC SCREWDRIVER , MODEL IA-400
K100600 · EKX Handpiece, Direct Drive,... · Dental
Jul 2010 128d
W&H HANDPIECE ANESTO, MODEL: RA-5
K083811 · EGM Injector, Jet,... · Dental
Jan 2010 388d
CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR
K090931 · EKX Handpiece, Direct Drive,... · Dental
Dec 2009 257d
CONTRA-ANGLE HANDPIECE KOMET OS30
K090548 · EFB Handpiece, Air-powered,... · Dental
Jun 2009 120d
SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
K080939 · KMW Handpiece, Rotary Bone... · Dental
Jul 2008 117d
DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
K060287 · EBW Controller, Foot,... · Dental
May 2006 86d
IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES
K052741 · EBW Controller, Foot,... · Dental
Jan 2006 105d
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
K014068 · EBW Controller, Foot,... · Dental
May 2002 144d
SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11
K011061 · EGS Handpiece, Contra- And... · Dental
Jun 2001 83d
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
K002469 · EBW Controller, Foot,... · Dental
Feb 2001 180d
SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD
K984508 · DZA Drill, Dental, Intraoral · Dental
Jun 1999 189d
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