E-TYPE SPEED REDUCER CONTRA ANGLE
Device Facts
| Record ID | K970953 |
|---|---|
| Device Name | E-TYPE SPEED REDUCER CONTRA ANGLE |
| Applicant | Nsk Nakanishi, Inc. |
| Product Code | KMW · Dental |
| Decision Date | Apr 15, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4120 |
| Device Class | Class 2 |
Regulatory Classification
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.
