# K220329: G-CAM

- Pathway: 510(k) (Abbreviated)
- Applicant: Graphenano Dental S.L.
- Decided: Aug 16, 2022 after 193 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K043504 (2005). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160918: JUVORA Dental Disc, Ceramill PEEK by JUVORA, Juvora (2017) Summary page 4.

## Most influential descendants
- K253236: G-Block (2025), 0 descendants of its own

## Recalls of this device
- Oct 24, 2023 · Class II · Z-1192-2024: Machining error on cams renders the device unusable.

## Indications for use
G-CAM discs are intended to be used for the manufacture of full and partial removable dentures, implant overdentures as well as permanent and temporary restorations such as anterior or posterior crowns and bridges, inlays, onlays, vencers, copings and substructures.

Source page: https://510kreport.com/device/K220329
Methodology: https://510kreport.com/methodology