The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Temrex Dental Polishing Paste.
| Device ID | K852157 |
| 510k Number | K852157 |
| Device Name: | TEMREX DENTAL POLISHING PASTE |
| Classification | Agent, Polishing, Abrasive, Oral 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 | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-17 |
| Decision Date | 1985-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850015110474 | K852157 | 000 |