Product code KMW
- Device name
- Handpiece, Rotary Bone Cutting
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.4120
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211584 | Oral Surgery Contra | Nakanishi, Inc. | 2021-08-19 |
| K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. | 2017-11-21 |
| K162544 | OsteoMed PINNACLE Driver | Osteomed | 2017-04-04 |
| K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | W&H Dentalwerk Buermoos GmbH | 2008-07-29 |
| K994298 | FRIOS MICROSAW | Friadent GmbH | 2000-02-18 |
| K971692 | OSTEOPOWER SYSTEM AND ACCESSORIES | Osteomed Corp. | 1997-06-27 |
| K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE | Nsk Nakanishi, Inc. | 1997-04-15 |
| K932255 | YOUNG D'GRANULATOR | Young Dental Manufacturing Co. 1, LLC | 1994-04-15 |
| K862110 | OSSEODENT DRILLING SYSTEM | Otc/America | 1986-08-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810126043153 | SM7 US ( Complete Set ) | HIOSSEN, INC. | 2026-01-09 |
| 00810126043160 | S200EML (Contra) Dental Surgery Hand Piece | HIOSSEN, INC. | 2026-01-09 |
| 04589551388813 | SG20M | NAKANISHI INC. | 2025-08-28 |
| 04589551388820 | X-SG20ML | NAKANISHI INC. | 2025-08-28 |
| 04560264576940 | SG20M | NAKANISHI INC. | 2025-08-28 |
| 04560264576957 | X-SG20ML | NAKANISHI INC. | 2025-08-28 |
| J021101008030 | S-8 S | W & H Dentalwerk Bürmoos GmbH | 2025-08-26 |
| J021101008010 | S-8 R | W & H Dentalwerk Bürmoos GmbH | 2025-08-26 |
| J021101008020 | S-8 O | W & H Dentalwerk Bürmoos GmbH | 2025-08-26 |
| J021101008031 | S-8 S | W & H Dentalwerk Bürmoos GmbH | 2025-08-26 |
| J021101008021 | S-8 O | W & H Dentalwerk Bürmoos GmbH | 2025-08-26 |
| J021101008011 | S-8 R | W & H Dentalwerk Bürmoos GmbH | 2025-08-26 |
| 06974267891104 | COXO | Foshan COXO Medical Instrument Co.,Ltd. | 2024-07-04 |
| 06974267891067 | COXO | Foshan COXO Medical Instrument Co.,Ltd. | 2024-03-30 |
| J021300320020 | WS-75 LG surgical handpiece, 20:1, MIS | W & H Dentalwerk Bürmoos GmbH | 2023-07-11 |
| J021300320021 | WS-75 LG surgical handpiece, 20:1, MIS | W & H Dentalwerk Bürmoos GmbH | 2023-07-11 |
| 04589551382446 | X-SG93L | NAKANISHI INC. | 2022-02-17 |
| 04589551382460 | X-SG25L | NAKANISHI INC. | 2022-02-17 |
| 04589551382453 | X-SG93 | NAKANISHI INC. | 2022-02-17 |
| 00840117305182 | Plastic Overbed Table, H Base, Silver Vein, Mahogany | Dynarex Corporation | 2021-04-22 |
| 00840117305168 | Plastic Overbed Table, H Base, Silver Vein, Cherry | Dynarex Corporation | 2021-04-22 |
| 00840117305151 | Plastic Overbed Table, H Base, Silver Vein, Grey | Dynarex Corporation | 2021-04-22 |
| 00814913029603 | SM3 | HIOSSEN, INC. | 2021-01-20 |
| 08800000995229 | SM3 | Osstem Implant Co., Ltd._Gasan Branch | 2019-04-25 |
| 04560264557628 | S-Max M | NAKANISHI INC. | 2018-08-20 |
| 04560264557611 | Ti-Max X | NAKANISHI INC. | 2018-08-20 |
| 04560264556287 | Surgical Angle Handpiece | NAKANISHI INC. | 2018-01-22 |
| 04560264556270 | Surgical Straight Handpiece | NAKANISHI INC. | 2018-01-22 |
| J021069909001 | Screw Holder for WS-90 | W & H Dentalwerk Bürmoos GmbH | 2016-09-24 |
| J021069909041 | Screw Holder 3mm | W & H Dentalwerk Bürmoos GmbH | 2016-09-24 |