# K202920: OptiComp

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent, Inc.
- Decided: May 25, 2022 after 603 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
OptiComp is a light cured hybrid dental restorative composite material used for direct restorations in all classes of cavities, including veneers and incisal edge repairs, and indirect anterior and posterior restorations, including inlays, onlays, and veneers.

Source page: https://510kreport.com/device/K202920
Methodology: https://510kreport.com/methodology