The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Interim, Temporary Cement.
| Device ID | K884081 |
| 510k Number | K884081 |
| Device Name: | INTERIM, TEMPORARY CEMENT |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-27 |
| Decision Date | 1988-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816526020176 | K884081 | 000 |
| D801SP55252B1 | K884081 | 000 |
| D801SP55251N1 | K884081 | 000 |
| D801SP55251B1 | K884081 | 000 |
| D801SP55251 | K884081 | 000 |
| D801SFRC1 | K884081 | 000 |
| D801ID5526I1 | K884081 | 000 |
| D801ID5525I1 | K884081 | 000 |
| D80155261N1 | K884081 | 000 |
| D686522003 | K884081 | 000 |
| D6860522101 | K884081 | 000 |
| D801SP55252N1 | K884081 | 000 |
| D801SP55253B1 | K884081 | 000 |
| 00816526020169 | K884081 | 000 |
| 00850015110061 | K884081 | 000 |
| 00850015110054 | K884081 | 000 |
| D801SP55261 | K884081 | 000 |
| D801SP5525S1 | K884081 | 000 |
| D801SP55256N1 | K884081 | 000 |
| D801SP55256B1 | K884081 | 000 |
| D801SP55254N1 | K884081 | 000 |
| D801SP55254B1 | K884081 | 000 |
| D801SP55253N1 | K884081 | 000 |
| D6860522051 | K884081 | 000 |