Company ยท AT
W&H Dentalwerk Buermoos GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2026. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (1 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | 5 |
| EFB | Handpiece, Air-Powered, Dental | 3 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 3 |
| DZI | Drill, Bone, Powered | 2 |
| KMW | Handpiece, Rotary Bone Cutting | 2 |
| DZA | Drill, Dental, Intraoral | 1 |
| EGM | Injector, Jet, Mechanical-Powered | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 2026 | K253776 | Implantmed Plus II & Piezomed Plus II Module W&H Dentalwerk Buermoos GmbH, AT | DZI |
| Jul 3, 2025 | K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessori W&H Dentalwerk Buermoos GmbH, AT | ERL |
| Feb 24, 2021 | K201703 | PROXEO Twist Cordless Polishing System PL-40 H W&H Dentalwerk Buermoos GmbH, AT | EKX |
| Mar 26, 2019 | K181858 | Electric Handpiece Motor W&H Dentalwerk Buermoos GmbH, AT | EBW |
| Dec 8, 2017 | K171553 | W&H Assistina Twin W&H Dentalwerk Buermoos GmbH, AT | EFB |
| Nov 23, 2015 | K143704 | Advanced Air System W&H Dentalwerk Buermoos GmbH, AT | EFB |
| Oct 16, 2014 | K133488 | PIEZOMED W&H Dentalwerk Buermoos GmbH, AT | DZI |
| Jul 9, 2010 | K100600 | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 W&H Dentalwerk Buermoos GmbH, AT | EKX |
| Jan 14, 2010 | K083811 | W&H HANDPIECE ANESTO, MODEL: RA-5 W&H Dentalwerk Buermoos GmbH, AT | EGM |
| Dec 15, 2009 | K090931 | CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR W&H Dentalwerk Buermoos GmbH, AT | EKX |
| Jun 30, 2009 | K090548 | CONTRA-ANGLE HANDPIECE KOMET OS30 W&H Dentalwerk Buermoos GmbH, AT | EFB |
| Jul 29, 2008 | K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES W&H Dentalwerk Buermoos GmbH, AT | KMW |
| May 3, 2006 | K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM W&H Dentalwerk Buermoos GmbH, AT | EBW |
| Jan 13, 2006 | K052741 | IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES W&H Dentalwerk Buermoos GmbH, AT | EBW |
| May 3, 2002 | K014068 | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 W&H Dentalwerk Buermoos GmbH, AT | EBW |
| Jun 28, 2001 | K011061 | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 W&H Dentalwerk Buermoos GmbH, AT | EGS |
| Feb 7, 2001 | K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) W&H Dentalwerk Buermoos GmbH, AT | EBW |
| Jun 25, 1999 | K984508 | SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD W&H Dentalwerk Buermoos GmbH, AT | DZA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2024 | W&H DENTALWERK BUERMOOS GMBH W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue
Model Number: 30061000 Open, Classified |
KMW | K080939 |
| Jul 25, 2011 | W & H DentalWerk Buermoos GMBH Arthrex Reciprocating Saw Attachment
Type: V-600SR
Distributed by: Arthrex Inc., Naples, Florida United States
The system Is a modular electric system, consisting of a handpiece drive, various acces Terminated |
HWE | None listed |