# K151842: Rainbow Shine

- Pathway: 510(k) (Traditional)
- Applicant: Genoss
- Decided: Jan 14, 2016 after 191 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: 4 generations back to K980986 (1998). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092513: Rainbow Block, Genoss Co., Ltd. (2009) Summary page 4.

## Most influential descendants
- K160079: rainbow Shine (2016), 1 descendant of its own
- K232174: rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono (2024), 0 descendants of its own

## Indications for use
rainbow™ Shine is used in the manufacture of a dental core through milling by machine (MAD/MAM or CAD/CAM) followed by sintering.

Source page: https://510kreport.com/device/K151842
Methodology: https://510kreport.com/methodology