K901967 is an FDA 510(k) clearance for the DENDIA WERK BURS AND CUTTING DISCS. This device is classified as a Instrument, Diamond, Dental (Class I - General Controls, product code DZP).
Submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on July 13, 1990, 73 days after receiving the submission on May 1, 1990.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4535.
| 510(k) Number | K901967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1990 |
| Decision Date | July 13, 1990 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DZP — Instrument, Diamond, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4535 |