MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55
Device Facts
| Record ID | K042434 |
|---|---|
| Device Name | MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 |
| Applicant | NOUVAG AG |
| Product Code | DZI · Dental |
| Decision Date | Nov 3, 2004 |
| 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.
