The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Diamond-luster Dental Polishing Paste.
| Device ID | K873686 |
| 510k Number | K873686 |
| Device Name: | DIAMOND-LUSTER DENTAL POLISHING 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 | 1987-09-14 |
| Decision Date | 1987-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D801SP5505U2G1 | K873686 | 000 |
| D801SP5505N1 | K873686 | 000 |
| D801SP5505B1 | K873686 | 000 |
| 00850015110481 | K873686 | 000 |
| 00816526022415 | K873686 | 000 |