The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Cavity Cleanser.
| Device ID | K832497 |
| 510k Number | K832497 |
| Device Name: | CAVITY CLEANSER |
| Classification | Varnish, Cavity |
| Applicant | DEN-MAT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-27 |
| Decision Date | 1983-10-04 |