Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

W&H Dentalwerk Buermoos GmbH · Predicate Candidate Screening

18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

192 daysmedian FDA review time
337 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253776Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbH2026-06-182040
K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-W&H Dentalwerk Buermoos GmbH2025-07-032590
K201703PROXEO Twist Cordless Polishing System PL-40 HW&H Dentalwerk Buermoos GmbH2021-02-242470
K181858Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH2019-03-262570
K171553W&H Assistina TwinW&H Dentalwerk Buermoos GmbH2017-12-081920
K143704Advanced Air SystemW&H Dentalwerk Buermoos GmbH2015-11-233290
K133488PIEZOMEDW&H Dentalwerk Buermoos GmbH2014-10-163370
K100600PROSTHODONTIC SCREWDRIVER , MODEL IA-400W&H Dentalwerk Buermoos GmbH2010-07-091280
K083811W&H HANDPIECE ANESTO, MODEL: RA-5W&H Dentalwerk Buermoos GmbH2010-01-143880
K090931CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDW&H Dentalwerk Buermoos GmbH2009-12-152570
K090548CONTRA-ANGLE HANDPIECE KOMET OS30W&H Dentalwerk Buermoos GmbH2009-06-301200
K080939SURGICAL HANDPIECES, MIKRO SAW HANDPIECESW&H Dentalwerk Buermoos GmbH2008-07-291171
K060287DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEMW&H Dentalwerk Buermoos GmbH2006-05-03860
K052741IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VEW&H Dentalwerk Buermoos GmbH2006-01-131050
K014068ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-2W&H Dentalwerk Buermoos GmbH2002-05-031440
K011061SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-9W&H Dentalwerk Buermoos GmbH2001-06-28830
K002469IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)W&H Dentalwerk Buermoos GmbH2001-02-071800
K984508SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 98W&H Dentalwerk Buermoos GmbH1999-06-251890

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda