DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS
Device Facts
| Record ID | K940908 |
|---|---|
| Device Name | DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS |
| Applicant | Dunhall Pharmaceuticals, Inc. |
| Product Code | DZP · Dental |
| Decision Date | Aug 29, 1994 |
| 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.
