MD 10, SEM, SM 12, CBM
Device Facts
| Record ID | K000710 |
|---|---|
| Device Name | MD 10, SEM, SM 12, CBM |
| Applicant | NOUVAG AG |
| Product Code | EFB · Dental |
| Decision Date | May 11, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4200 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
