# K253236: G-Block

- Pathway: 510(k) (Abbreviated)
- Applicant: Graphenano Dental S.L.
- Decided: Sep 29, 2025 after 0 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: 5 generations back to K043504 (2005). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220329: G-CAM, Graphenano Dental S.L. (2022) Summary page 5.

## Indications for use
G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.

Source page: https://510kreport.com/device/K253236
Methodology: https://510kreport.com/methodology