The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Univar Universal Dentin Varnish.
| Device ID | K852755 |
| 510k Number | K852755 |
| Device Name: | UNIVAR UNIVERSAL DENTIN VARNISH |
| Classification | Varnish, Cavity |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Contact | Jan Orlowski |
| Correspondent | Jan Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-28 |
| Decision Date | 1985-09-23 |