# K222723: AMBARINO High-Class

- Pathway: 510(k) (Traditional)
- Applicant: Creamed GmbH & Co. Produktions- Und Handels KG
- Decided: Sep 9, 2022 after 1 day
- 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: 1 generation back to K130841 (2013). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130841: Shofu Block HC, Shofu Dental Corporation (2013) Summary page 4.

## Most influential descendants
- K261357: Grandio disc multicolor (2026), 0 descendants of its own
- K223742: Dental Ceramic Blocks (2023), 0 descendants of its own

## Indications for use
AMBARINO® High-Class is indicated for fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.

Source page: https://510kreport.com/device/K222723
Methodology: https://510kreport.com/methodology