The following data is part of a premarket notification filed by Alpha Industrializacao De Metais Ltda. with the FDA for Dental Diamond Drills.
| Device ID | K923757 |
| 510k Number | K923757 |
| Device Name: | DENTAL DIAMOND DRILLS |
| Classification | Instrument, Diamond, Dental |
| Applicant | ALPHA INDUSTRIALIZACAO DE METAIS LTDA. RUA AUREA TAVARES 450 CEP 06765 Taboso De Serra Brazil, BR |
| Product Code | DZP |
| CFR Regulation Number | 872.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-28 |
| Decision Date | 1993-03-16 |