The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Fluoroseal, Dentin Sealer And Cavity Liner.
| Device ID | K860633 |
| 510k Number | K860633 |
| Device Name: | FLUOROSEAL, DENTIN SEALER AND CAVITY LINER |
| Classification | Varnish, Cavity |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Contact | Jan A Orlowski |
| Correspondent | Jan A 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 | 1986-02-20 |
| Decision Date | 1986-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816526021395 | K860633 | 000 |
| D801SP7503S1 | K860633 | 000 |
| D801SP75036B1 | K860633 | 000 |
| D801SP75035Z1 | K860633 | 000 |
| D801SP75035BS1 | K860633 | 000 |
| D801SP75035B1 | K860633 | 000 |
| D801SP750351 | K860633 | 000 |
| D801SP75031NB1 | K860633 | 000 |
| D801SP75031BS1 | K860633 | 000 |
| D801SP75031B1 | K860633 | 000 |
| D801SP75031 | K860633 | 000 |
| D801SP72036B1 | K860633 | 000 |
| D801SP75131 | K860633 | 000 |
| D801SP75131B1 | K860633 | 000 |
| D801SP75131BS1 | K860633 | 000 |
| 00816526021388 | K860633 | 000 |
| 00816526021371 | K860633 | 000 |
| 00816526021173 | K860633 | 000 |
| 00816526021166 | K860633 | 000 |
| 00816526020053 | K860633 | 000 |
| 00816526020046 | K860633 | 000 |
| 00816526020039 | K860633 | 000 |
| 00816526020022 | K860633 | 000 |
| 00816526020015 | K860633 | 000 |
| 00816526020008 | K860633 | 000 |
| D801SP75131N1 | K860633 | 000 |
| D801ID75035IZ1 | K860633 | 000 |