K771973 is an FDA 510(k) clearance for the GINGITRACT. This device is classified as a Retractor, All Types (Class I - General Controls, product code EIG).
Submitted by Den-Mat Corp. (Walker, US). The FDA issued a Cleared decision on November 7, 1977, 21 days after receiving the submission on October 17, 1977.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K771973 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 1977 |
| Decision Date | November 07, 1977 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIG — Retractor, All Types |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |