Surgical devices · 21 CFR 872 Subpart E
Rotary Bone Cutting Handpiece
FDA device type “Handpiece, Rotary Bone Cutting”.
- Companies listing it
- 175 makers
- Brands and models
- 77
- 510(k) clearances
- 90 in five years
- FDA name
- Handpiece, Rotary Bone Cutting
510(k) clearances per year, 1976–2026
Companies that list KMW
17 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Nakanishi, Inc. | Japan | Maker | E-TYPE SPEED REDUCER CONTRA ANGLE · FC-78 · SG20 · SG20M · +59 | 37 | 2026 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Dental Electrical Motors; C-PUMA MASTER · Dental Implantation Systems; C-Sailor Pro | 6 | 2025 |
| Osteomed, LLC | United States | Maker | — | 26 | 2022 |
| W&H Dentalwerk Buermoos GmbH | Austria | Maker | — | 17 | 2026 |
| Onvet Medical Canada Inc. | Canada | Maker | iTesla Dental Implant System | — | — |
| Dentsply Sirona, Inc. | United States | Contract manufacturer | Contra-angle | 148 | 2026 |
| Nobel Biocare Services AG | Switzerland | Contract manufacturer | Surgical Handpiece | 94 | 2026 |
| Hiossen Inc. | United States | Manufacturer | SM3 | 26 | 2026 |
| Paltop Advanced Dental Solutions Inc. | United States | Contract manufacturer | Contra Angle NSK | 7 | 2025 |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| Sweden & Martina INC | United States | Lister | CONTRAANGLE FOR SURGERY 1:1 · CONTRAANGLE FOR SURGERY 20:1 | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Dental Electric Motor / Dental Implantation System | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | TOYO MEDICAL CO | — | — |
| Henry Schein MSO, LLC | United States | Repacker / relabeler | NSK | — | — |
| W&H Impex Inc. | Canada | Foreign exporter | — | — | — |
| Sanicure BV | Netherlands | Foreign exporter | HANDPIECE, ROTARY BONE CUTTING | — | — |
| Zapalign LLC | United States | Repacker / relabeler | HANDPIECE, ROTARY BONE CUTTING | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 19 Aug 2021 | K211584 | Oral Surgery Contra | Nakanishi, Inc. |
| 21 Nov 2017 | K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. |
| 4 Apr 2017 | K162544 | OsteoMed PINNACLE Driver | Osteomed, LLC |
| 29 Jul 2008 | K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | W&H Dentalwerk Buermoos GmbH |
| 18 Feb 2000 | K994298 | FRIOS MICROSAW | Friadent GmbH |
| 27 Jun 1997 | K971692 | OSTEOPOWER SYSTEM AND ACCESSORIES | Osteomed, LLC |
| 15 Apr 1997 | K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE | Nsk Nakanishi, Inc. |
| 15 Apr 1994 | K932255 | YOUNG D'GRANULATOR | Young Innovations Inc |
| 7 Aug 1986 | K862110 | OSSEODENT DRILLING SYSTEM | Otc/America |
Official records: FDA product classification for KMW · 21 CFR 872.4120.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026