The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Luster, Dental Polishing Paste.
| Device ID | K842403 |
| 510k Number | K842403 |
| Device Name: | LUSTER, DENTAL POLISHING PASTE |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-19 |
| Decision Date | 1984-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D801SP5005S1 | K842403 | 000 |
| D801SP50051N1 | K842403 | 000 |
| D801SP50051B1 | K842403 | 000 |
| D801SP50051 | K842403 | 000 |
| D801ID5005I1 | K842403 | 000 |
| 00816526022422 | K842403 | 000 |