K923883 is an FDA 510(k) clearance for the DENTAL OR SURGICAL BUR. This device is classified as a Bur, Dental (Class I - General Controls, product code EJL).
Submitted by Stratum Dental Technologies, Inc. (Las Vegas, US). The FDA issued a Cleared decision on July 27, 1993, 357 days after receiving the submission on August 4, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3240.
| 510(k) Number | K923883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1992 |
| Decision Date | July 27, 1993 |
| Days to Decision | 357 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJL — Bur, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3240 |