F.G. LASER (DENTAL BUR)
Device Facts
| Record ID | K901262 |
|---|---|
| Device Name | F.G. LASER (DENTAL BUR) |
| Applicant | Diamond Rotary and Carbide Intl. |
| Product Code | DZP · Dental |
| Decision Date | Jul 9, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4535 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A dental diamond instrument is an abrasive device intended to smooth tooth surfaces during the fitting of crowns or bridges. The device consists of a shaft which is inserted into a handpiece and a head which has diamond chips imbedded into it. Rotation of the diamond instrument provides an abrasive action when it contacts a tooth.
