K771347 is an FDA 510(k) clearance for the R&R ALSTON CARBIDE BURS. This device is classified as a Bur, Dental (Class I - General Controls, product code EJL).
Submitted by Ransom and Randolph (Mchenry, US). The FDA issued a Cleared decision on August 3, 1977, 14 days after receiving the submission on July 20, 1977.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3240.
| 510(k) Number | K771347 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1977 |
| Decision Date | August 03, 1977 |
| Days to Decision | 14 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 |