KMW
9 FDA 510(k) clearances · Product code
87 daysmedian time to decision
340 days90th percentile
9clearances measured
FDA profile
- Official device name
- Handpiece, Rotary Bone Cutting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.4120
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2021: 32 · 2022: 54 · 2023: 25 · 2024: 49 · 2025: 24 · 2026: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Oral Surgery Contra (K211584) | Nakanishi, Inc. | 2021-08-19 |
| Surgical Angle Handpiece, Surgical Straight Handpiece (K171155) | Nakanishi, Inc. | 2017-11-21 |
| OsteoMed PINNACLE Driver (K162544) | Osteomed | 2017-04-04 |
| SURGICAL HANDPIECES, MIKRO SAW HANDPIECES (K080939) | W&H Dentalwerk Buermoos GmbH | 2008-07-29 |
| FRIOS MICROSAW (K994298) | Friadent GmbH | 2000-02-18 |
| OSTEOPOWER SYSTEM AND ACCESSORIES (K971692) | Osteomed Corp. | 1997-06-27 |
| E-TYPE SPEED REDUCER CONTRA ANGLE (K970953) | Nsk Nakanishi, Inc. | 1997-04-15 |
| YOUNG D'GRANULATOR (K932255) | Young Dental Manufacturing Co. 1, LLC | 1994-04-15 |
| OSSEODENT DRILLING SYSTEM (K862110) | Otc/America | 1986-08-07 |
Track KMW automatically
Every clearance here is in the API, with alerts when new ones post.