The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for E.z. Temep, Temporary Filling Material.
| Device ID | K924132 |
| 510k Number | K924132 |
| Device Name: | E.Z. TEMEP, TEMPORARY FILLING MATERIAL |
| Classification | Cement, Dental |
| Applicant | COSMEDENT, INC. 5419 NORTH SHERIDAN RD. Chicago, IL 60640 |
| Contact | Michael O'malley |
| Correspondent | Michael O'malley COSMEDENT, INC. 5419 NORTH SHERIDAN RD. Chicago, IL 60640 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-17 |
| Decision Date | 1993-07-08 |