The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Gingitract.
| Device ID | K771973 |
| 510k Number | K771973 |
| Device Name: | GINGITRACT |
| Classification | Retractor, All Types |
| Applicant | DEN-MAT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EIG |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-17 |
| Decision Date | 1977-11-07 |