KMW · Handpiece, Rotary Bone Cutting
Dental · 21 CFR 872.4120 · Class 2
Overview
| Product Code | KMW |
|---|---|
| Device Name | Handpiece, Rotary Bone Cutting |
| Regulation | 21 CFR 872.4120 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.
Classification Rationale
Class II.
Cleared Devices (9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K211584 | Oral Surgery Contra | Nakanishi, Inc. | Aug 19, 2021 | SESE |
| K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. | Nov 21, 2017 | SESE |
| K162544 | OsteoMed PINNACLE Driver | Osteomed | Apr 4, 2017 | SESE |
| K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | W&H Dentalwerk Buermoos GmbH | Jul 29, 2008 | SESE |
| K994298 | FRIOS MICROSAW | Friadent GmbH | Feb 18, 2000 | SESE |
| K971692 | OSTEOPOWER SYSTEM AND ACCESSORIES | Osteomed Corp. | Jun 27, 1997 | SESE |
| K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE | Nsk Nakanishi, Inc. | Apr 15, 1997 | SESE |
| K932255 | YOUNG D'GRANULATOR | Young Dental Manufacturing Co. 1, LLC | Apr 15, 1994 | SESE |
| K862110 | OSSEODENT DRILLING SYSTEM | Otc/America | Aug 7, 1986 | SESE |
Top Applicants
- Nakanishi, Inc. — 2 clearances
- Young Dental Manufacturing Co. 1, LLC — 1 clearance
- W&H Dentalwerk Buermoos GmbH — 1 clearance
- Otc/America — 1 clearance
- Osteomed Corp. — 1 clearance
