TECHMEDICA I.B.O. BLADE
Device Facts
| Record ID | K883922 |
|---|---|
| Device Name | TECHMEDICA I.B.O. BLADE |
| Applicant | Techmedica, Inc. |
| Product Code | DZJ · Dental |
| Decision Date | Dec 8, 1988 |
| 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.
