W&H DENTALWERK BUERMOOS GMBH
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 17
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1168-2024 | Class II | W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000 | January 16, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various | July 3, 2025 |
| K201703 | PROXEO Twist Cordless Polishing System PL-40 H | February 24, 2021 |
| K181858 | Electric Handpiece Motor | March 26, 2019 |
| K171553 | W&H Assistina Twin | December 8, 2017 |
| K143704 | Advanced Air System | November 23, 2015 |
| K133488 | PIEZOMED | October 16, 2014 |
| K100600 | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 | July 9, 2010 |
| K083811 | W&H HANDPIECE ANESTO, MODEL: RA-5 | January 14, 2010 |
| K090931 | CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR | December 15, 2009 |
| K090548 | CONTRA-ANGLE HANDPIECE KOMET OS30 | June 30, 2009 |
| K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | July 29, 2008 |
| K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | May 3, 2006 |
| K052741 | IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES | January 13, 2006 |
| K014068 | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 | May 3, 2002 |
| K011061 | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES | June 28, 2001 |
| K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) | February 7, 2001 |
| K984508 | SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STR | June 25, 1999 |