# K210817: C&B 5.0 Hybrid

- Pathway: 510(k) (Traditional)
- Applicant: Arum Dentistry Co., Ltd.
- Decided: Dec 8, 2021 after 265 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K070991 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180657: Resin for Temporary Crown & Bridge, Dentis Co., Ltd. (2018) Summary page 4.

## Indications for use
C&B 5.0 Hybrid resin is a light-curable polymerizable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges and require digital models of crowns or bridges, a stereolithographic additive printer, and curing light equipment.

Source page: https://510kreport.com/device/K210817
Methodology: https://510kreport.com/methodology