Home › Device types › KMW
Handpiece, Rotary Bone Cutting
FDA product code KMW · Class 2 · Dental
446
Registered devices
309
Adverse events
10
Recalls
9
510(k) clearances
Devices with this code
OsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCSurgical Angle Handpiece — NAKANISHI INC.OsteoMed — OSTEOMED LLCSGQ-ER20h — NAKANISHI INC.OsteoMed — OSTEOMED LLCS-15 surgical handpiece 1:1 — W & H Dentalwerk Bürmoos GmbHOsteoMed — OSTEOMED LLCTi-Max X — NAKANISHI INC.OsteoMed — OSTEOMED LLCX-SG20ML — NAKANISHI INC.SGO-3 — NAKANISHI INC.Micro Surgery Handpiece — NAKANISHI INC.OsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCZygoma SZ-75 — W & H Dentalwerk Bürmoos GmbHS-12 surgical handpiece 1:2 — W & H Dentalwerk Bürmoos GmbHS-16 Surgical Handpiece 1:2 — W & H Dentalwerk Bürmoos GmbHOsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCOsteoMed — OSTEOMED LLCTurning Handle — W & H Dentalwerk Bürmoos GmbHOsteoMed — 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.