The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Photac-bond Aplicap, Modification.
| Device ID | K915005 |
| 510k Number | K915005 |
| Device Name: | PHOTAC-BOND APLICAP, MODIFICATION |
| Classification | Cement, Dental |
| Applicant | ESPE GMBH (US) FABRIK PHARMAZEUTISCHER D-8031 SEEFELD/OBERBAY West Germany, DE |
| Contact | Brechenmacher |
| Correspondent | 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 | 1991-11-07 |
| Decision Date | 1992-01-14 |