The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Temporex.
| Device ID | K903551 |
| 510k Number | K903551 |
| Device Name: | TEMPOREX |
| 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 | 1990-08-06 |
| Decision Date | 1990-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817051020044 | K903551 | 000 |
| D801SP50601B1 | K903551 | 000 |
| D801SP50601N1 | K903551 | 000 |
| D801SP50602B1 | K903551 | 000 |
| D801SP50602N1 | K903551 | 000 |
| D801SP50603B1 | K903551 | 000 |
| D801SP50603N1 | K903551 | 000 |
| D801SP5060S1 | K903551 | 000 |
| 00850015110344 | K903551 | 000 |
| 00816526021265 | K903551 | 000 |
| 00817051020037 | K903551 | 000 |
| D801SP50601 | K903551 | 000 |