EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES
Device Facts
| Record ID | K141183 |
|---|---|
| Device Name | EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES |
| Applicant | Ttbio Corp. |
| Product Code | EFB · Dental |
| Decision Date | Feb 27, 2015 |
| Decision | SESE |
| Submission Type | Abbreviated |
| 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.
