# K261357: Grandio disc multicolor

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Apr 27, 2026 after 3 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: 2 generations back to K130841 (2013). 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)
- K222723: AMBARINO High-Class, Creamed GmbH & Co. Produktions- Und Handels KG (2022) Summary page 5.

## Indications for use
Customised crowns, inlays, onlays, veneers and implant-retained crowns, 3-unit bridges as well as veneers of frameworks of indirect restorations in the anterior and posterior regions. Fields of application: Lack of tooth substance, partial edentulism and complete edentulism. Indication: Without framework - Inlays, onlays, veneers - Crowns, implant-retained crowns - 3-unit bridges (not Inlay bridges, Cantilever bridges and Maryland bridges) With supporting framework - Veneers of supporting frameworks irrespective of the selected manufacturing process.

Source page: https://510kreport.com/device/K261357
Methodology: https://510kreport.com/methodology