The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Dental Cavity Varnish, Concentrated.
| Device ID | K800438 |
| 510k Number | K800438 |
| Device Name: | DENTAL CAVITY VARNISH, CONCENTRATED |
| Classification | Varnish, Cavity |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 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 | 1980-02-28 |
| Decision Date | 1980-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D801SP7103N1 | K800438 | 000 |
| D801SP7001N1 | K800438 | 000 |
| D801SP7001SB1 | K800438 | 000 |
| D801SP70021 | K800438 | 000 |
| D801SP7002B1 | K800438 | 000 |
| D801SP7003B1 | K800438 | 000 |
| D801SP7003N1 | K800438 | 000 |
| D801SP7003SB1 | K800438 | 000 |
| D801SP70041 | K800438 | 000 |
| D801SP71031 | K800438 | 000 |
| D801SP7001B1 | K800438 | 000 |