The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Denture-tight.
| Device ID | K790589 |
| 510k Number | K790589 |
| Device Name: | DENTURE-TIGHT |
| Classification | Reliner, Denture, Over The Counter |
| Applicant | DEN-MAT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBP |
| CFR Regulation Number | 872.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-27 |
| Decision Date | 1979-08-10 |