PHASE CHANGE DENTAL LUBRICANT
Device Facts
| Record ID | K954991 |
|---|---|
| Device Name | PHASE CHANGE DENTAL LUBRICANT |
| Applicant | Phase Change |
| Product Code | EFB · Dental |
| Decision Date | Jan 4, 1996 |
| 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.
