The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Photac-fil Aplicap.
| Device ID | K925027 |
| 510k Number | K925027 |
| Device Name: | PHOTAC-FIL APLICAP |
| Classification | Cement, Dental |
| Applicant | ESPE GMBH (US) FABRIK PHARMAZEUTISCHER D-8031 SEEFELD/OBERBAY West Germany, DE |
| Contact | Antje Brechenmacher |
| Correspondent | Antje Brechenmacher ESPE GMBH (US) FABRIK PHARMAZEUTISCHER D-8031 SEEFELD/OBERBAY West Germany, DE |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-02 |
| Decision Date | 1993-06-18 |