K760985 is an FDA 510(k) clearance for the HAND INSTRUMENTS. This device is classified as a Broach, Endodontic (Class I - General Controls, product code EKW).
Submitted by Adp Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1976, 25 days after receiving the submission on October 21, 1976.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K760985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1976 |
| Decision Date | November 15, 1976 |
| Days to Decision | 25 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 |