The following data is part of a premarket notification filed by Medental Intl. with the FDA for Cavity Varnish (intermediary Varnish And Dentinal Tubuli Seal).
| Device ID | K973919 |
| 510k Number | K973919 |
| Device Name: | CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) |
| Classification | Varnish, Cavity |
| Applicant | MEDENTAL INTL. 1246 CLEAR CREEK RD. Evergreen, CO 80434 |
| Contact | Debra Gillaspy |
| Correspondent | Debra Gillaspy MEDENTAL INTL. 1246 CLEAR CREEK RD. Evergreen, CO 80434 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-15 |
| Decision Date | 1997-12-16 |