The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Carbocem Zinc Polycarboxylate Cement.
| Device ID | K993324 |
| 510k Number | K993324 |
| Device Name: | CARBOCEM ZINC POLYCARBOXYLATE CEMENT |
| Classification | Cement, Dental |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 3221 PRODUCER WAY Pomona, CA 91768 -3916 |
| Contact | Jan A Orlowski |
| Correspondent | Jan A Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 3221 PRODUCER WAY Pomona, CA 91768 -3916 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-04 |
| Decision Date | 1999-11-09 |