The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Sci-pharm Unifil Anterior/posterior Liquid/paste.
| Device ID | K860627 |
| 510k Number | K860627 |
| Device Name: | SCI-PHARM UNIFIL ANTERIOR/POSTERIOR LIQUID/PASTE |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-19 |
| Decision Date | 1986-03-26 |