The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Espe(r) -sil.
| Device ID | K913965 |
| 510k Number | K913965 |
| Device Name: | ESPE(R) -SIL |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | ESPE GMBH (US) FABRIK PHARMAZEUTISCHER D-8031 SEEFELD/OBERBAY West Germany, DE |
| Contact | Dr. A Brechenmacher |
| Correspondent | Dr. A Brechenmacher ESPE GMBH (US) FABRIK PHARMAZEUTISCHER D-8031 SEEFELD/OBERBAY West Germany, DE |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-05 |
| Decision Date | 1991-12-04 |