Home › Device types › KMW
Handpiece, Rotary Bone Cutting
FDA product code KMW · Class 2 · Dental
443
Registered devices
309
Adverse events
10
Recalls
9
510(k) clearances
Devices with this code
S-Max M — NAKANISHI INC.OsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCSM3 — HIOSSEN, INC.OsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCSGO-6 — NAKANISHI INC.Ti-Max X — NAKANISHI INC.WI-75 LED G Implantology contra-angle, MIS — W & H Dentalwerk Bürmoos GmbHS-11 LED G 1:1 — W & H Dentalwerk Bürmoos GmbHER20i — NAKANISHI INC.OsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCSGA-E2S — NAKANISHI INC.OsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-16 | W&H DENTALWERK BUERMOOS GMBH | 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads |
| 2021-10-28 | Osteomed, LLC | Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient. |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave steri |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave steri |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave steri |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave steri |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave steri |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave steri |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave steri |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave steri |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.