TMJ CANNULA SET
Device Facts
| Record ID | K871648 |
|---|---|
| Device Name | TMJ CANNULA SET |
| Applicant | Aspen Laboratories, Inc. |
| Product Code | DZI · Dental |
| Decision Date | Jun 8, 1987 |
| 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.
