The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Sono(r) -cem.
| Device ID | K913966 |
| 510k Number | K913966 |
| Device Name: | SONO(R) -CEM |
| Classification | Material, Tooth Shade, 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-05 |
| Decision Date | 1992-01-14 |