# K110859: Metal Opaquer

- Pathway: 510(k) (Traditional)
- Applicant: Apex Dental Materials, Inc.
- Decided: Jun 23, 2011 after 87 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Metal Opaquer is a light activated (photo initiated, via free radical polymerization) opaquing composite material, designed for use as a tooth or white colored composite material to cover metal and create more aesthetically pleasing restorations. Metal Oapquer is a composite material which, when utilized properly, masks the metal appearance of dental implants, abutments or restorations with a tooth colored composite layer. Metal Opaquer is compatible with all other methacrylate based dental materials.

Source page: https://510kreport.com/device/K110859
Methodology: https://510kreport.com/methodology