K831749 is an FDA 510(k) clearance for the ENDODONTIC BROACH(76EKN) BARBED BROACH. This device is classified as a Broach, Endodontic (Class I - General Controls, product code EKW).
Submitted by Union Branch (Mchenry, US). The FDA issued a Cleared decision on July 12, 1983, 50 days after receiving the submission on May 23, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K831749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 1983 |
| Decision Date | July 12, 1983 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EKW — Broach, Endodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |