K780641 is an FDA 510(k) clearance for the DENTAL ROTARY CARBIDE BURS 76EJL. This device is classified as a Bur, Dental (Class I - General Controls, product code EJL).
Submitted by Teledyne Densco (Mchenry, US). The FDA issued a Cleared decision on April 21, 1978, 4 days after receiving the submission on April 17, 1978.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3240.
| 510(k) Number | K780641 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 1978 |
| Decision Date | April 21, 1978 |
| Days to Decision | 4 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EJL — Bur, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3240 |