# K123761: Vita Enamic Stains

- Pathway: 510(k) (Traditional)
- Applicant: Innovation Meditech GmbH
- Decided: Mar 1, 2013 after 84 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K211854: VITA Akzent LC (2021), 2 descendants of its own
- K240660: Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active (2024), 1 descendant of its own
- K251587: VITA VMLC Primer (2026), 0 descendants of its own
- K162408: Nano Varnish, Plaquit, Lightpaint on Surface (2018), 0 descendants of its own

## Indications for use
Vita Enamic® Stains are indicated for shade customization and characterization of the surface of dental restorations made of hybrid ceramic-resin and resin materials.

Source page: https://510kreport.com/device/K123761
Methodology: https://510kreport.com/methodology