The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Den-mat Dental Flosser.
| Device ID | K791223 |
| 510k Number | K791223 |
| Device Name: | DEN-MAT DENTAL FLOSSER |
| Classification | Floss, Dental |
| Applicant | DEN-MAT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JES |
| CFR Regulation Number | 872.6390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-03 |
| Decision Date | 1979-10-09 |