The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Premet, Metal Primer.
| Device ID | K884391 |
| 510k Number | K884391 |
| Device Name: | PREMET, METAL PRIMER |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-18 |
| Decision Date | 1989-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D801SP7010SB1 | K884391 | 000 |
| D801SP7010N1 | K884391 | 000 |
| D801SP7010B1 | K884391 | 000 |
| D801ID7010I1 | K884391 | 000 |