The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Sci-pro, Prophylaxis Paste.
| Device ID | K854828 |
| 510k Number | K854828 |
| Device Name: | SCI-PRO, PROPHYLAXIS PASTE |
| Classification | Agent, Polishing, Abrasive, Oral 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 | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-03 |
| Decision Date | 1986-03-26 |