# K232559: C&B NFH Hybrid

- Pathway: 510(k) (Traditional)
- Applicant: Arum Dentistry Co., Ltd.
- Decided: Sep 11, 2024 after 385 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: 8 generations back to K042819 (2004). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202846: Tera Harz, Graphy, Inc. (2021) Summary page 5.

## Indications for use
The C&B NFH Hybrid is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The C&B NFH Hybrid material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of C&B NFH Hybrid requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

Source page: https://510kreport.com/device/K232559
Methodology: https://510kreport.com/methodology