STATMATIC 31 HANDPIECE MAINTENANCE UNIT
Device Facts
| Record ID | K073319 |
|---|---|
| Device Name | STATMATIC 31 HANDPIECE MAINTENANCE UNIT |
| Applicant | Scican , Ltd. |
| Product Code | EFB · Dental |
| Decision Date | Feb 4, 2008 |
| 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.
