Handpiece, Rotary Bone Cutting
FDA product code KMW · Class II (moderate risk) · 21 CFR 872.4120 · Dental
9510(k) clearances
0PMA approvals
10recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K211584 | Oral Surgery ContraKMW · Traditional | Nakanishi, Inc. | 08/19/2021SE |
| K171155 | Surgical Angle Handpiece, Surgical Straight HandpieceKMW · Traditional | Nakanishi, Inc. | 11/21/2017SE |
| K162544 | OsteoMed PINNACLE DriverKMW · Traditional | Osteomed | 04/04/2017SE |
| K080939 | Surgical Handpieces, Mikro Saw HandpiecesKMW · Traditional | W&H Dentalwerk Buermoos GmbH | 07/29/2008SE |
| K994298 | Frios MicrosawKMW · Traditional | Friadent GmbH | 02/18/2000SE |
| K971692 | Osteopower System and AccessoriesKMW · Traditional | Osteomed Corp. | 06/27/1997SE |
| K970953 | E-Type Speed Reducer Contra AngleKMW · Traditional | Nsk Nakanishi, Inc. | 04/15/1997SE |
| K932255 | Young D'GranulatorKMW · Traditional | Young Dental Manufacturing Co. 1, LLC | 04/15/1994SE |
| K862110 | Osseodent Drilling SystemKMW · Traditional | Otc/America | 08/07/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1168-2024 Class II | W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number:…1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific… | W&H Dentalwerk Buermoos GmbH | 01/16/2024Open, Classified |
| Z-0335-2022 Class II | OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00…Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result… | Osteomed, LLC | 10/28/2021Open, Classified |
| Z-0226-2019 Class II | Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi…Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual… | Nakanishi Inc. | 06/01/2018Terminated |
| Z-0225-2019 Class II | Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi…Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual… | Nakanishi Inc. | 06/01/2018Terminated |
| Z-0224-2019 Class II | Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by:…Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual… | Nakanishi Inc. | 06/01/2018Terminated |
| Z-0223-2019 Class II | Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi…Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual… | Nakanishi Inc. | 06/01/2018Terminated |
| Z-0222-2019 Class II | Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical…Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual… | Nakanishi Inc. | 06/01/2018Terminated |
| Z-0221-2019 Class II | Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical…Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual… | Nakanishi Inc. | 06/01/2018Terminated |
| Z-0220-2019 Class II | Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical…Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual… | Nakanishi Inc. | 06/01/2018Terminated |
| Z-0219-2019 Class II | Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical…Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual… | Nakanishi Inc. | 06/01/2018Terminated |