# K090843: Amaris Gingiva Opaquer

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Jun 17, 2009 after 82 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001913 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001913: Clearfil ST Opaquer, Kuraray Company, Ltd. (2000) Summary page 1.

## Indications for use
Amaris® Gingiva Opaquer is intended for use in conjunction with Amaris Gingiva for the following applications: - for the aesthetic covering and masking of discoloured hypersensitive necks of teeth, especially in the visible anterior area. - for corrections of the red-white aesthetics. - for masking and lightening of crown and bridge restorations and margins.

Source page: https://510kreport.com/device/K090843
Methodology: https://510kreport.com/methodology