The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Visio-gem.
| Device ID | K833757 |
| 510k Number | K833757 |
| Device Name: | VISIO-GEM |
| Classification | Material, Tooth Shade, Resin |
| Applicant | ESPE GMBH (US) CA |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-26 |
| Decision Date | 1984-02-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VISIO-GEM 73442414 1313056 Dead/Cancelled |
Espe Fabrik Pharmazeutischer Praparate GmbH 1983-09-06 |