# K232174: rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono

- Pathway: 510(k) (Traditional)
- Applicant: Genoss Co., Ltd.
- Decided: Feb 23, 2024 after 217 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K980986 (1998). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160079: rainbow Shine, Genoss Co., Ltd. (2016) Summary page 5.

## Indications for use
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono is used in the manufacture of a dental core through milling by machine followed by sintering

Source page: https://510kreport.com/device/K232174
Methodology: https://510kreport.com/methodology