The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Visio-opaquer.
| Device ID | K822453 |
| 510k Number | K822453 |
| Device Name: | VISIO-OPAQUER |
| Classification | Material, Tooth Shade, Resin |
| Applicant | ESPE GMBH (US) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-16 |
| Decision Date | 1982-09-14 |