The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Den-mat Polishing Paste.
| Device ID | K801225 |
| 510k Number | K801225 |
| Device Name: | DEN-MAT POLISHING PASTE |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | DEN-MAT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-22 |
| Decision Date | 1980-06-17 |