# K130841: Shofu Block HC

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corporation
- Decided: Sep 11, 2013 after 169 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.
3 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K222723: AMBARINO High-Class (2022), 2 descendants of its own
- K261357: Grandio disc multicolor (2026), 0 descendants of its own
- K223742: Dental Ceramic Blocks (2023), 0 descendants of its own

## Indications for use
For fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental labs and manufacturers using a dental CAD/CAM system.

Source page: https://510kreport.com/device/K130841
Methodology: https://510kreport.com/methodology