# K240735: visio.lign color, visio.lign shield

- Pathway: 510(k) (Traditional)
- Applicant: Bredent GmbH & Co. KG
- Decided: Dec 12, 2024 after 269 days
- Product code: EBD (Coating, Filling Material, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K052462 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133836: Optiglaze Color, GC America, Inc. (2014) Summary page 5.

## Indications for use
visio.lign color: Characterization with colour effects on the surface of composite restorations, denture base materials and artificial denture teeth. visio.lign shield: Surface coating and wear resistance of composite restorations, denture base materials and artificial denture teeth.

Source page: https://510kreport.com/device/K240735
Methodology: https://510kreport.com/methodology