The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Amaris Gingiva Opaquer.
| Device ID | K090843 |
| 510k Number | K090843 |
| Device Name: | AMARIS GINGIVA OPAQUER |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | M. Th. Plaumann |
| Correspondent | M. Th. Plaumann VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-27 |
| Decision Date | 2009-06-17 |
| Summary: | summary |