IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
Device Facts
| Record ID | K002469 |
|---|---|
| Device Name | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) |
| Applicant | W&H Dentalwerk Buermoos GmbH |
| Product Code | EBW · Dental |
| Decision Date | Feb 7, 2001 |
| 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.
