3D DENTAL DIAMOND ROTARY INSTRUMENTS
Device Facts
| Record ID | K893844 |
|---|---|
| Device Name | 3D DENTAL DIAMOND ROTARY INSTRUMENTS |
| Applicant | Lustgarten Multi-Tech International, Inc. |
| Product Code | DZP · Dental |
| Decision Date | Aug 11, 1989 |
| 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.
