K900089 is an FDA 510(k) clearance for the FG DIAMOND BURRS. This device is classified as a Instrument, Diamond, Dental (Class I - General Controls, product code DZP).
Submitted by Kab Gloves Unltd. (Berkley, US). The FDA issued a Cleared decision on April 3, 1990, 88 days after receiving the submission on January 5, 1990.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4535.
| 510(k) Number | K900089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1990 |
| Decision Date | April 03, 1990 |
| Days to Decision | 88 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 |