# K151844: Rainbow Shade

- Pathway: 510(k) (Traditional)
- Applicant: Genoss
- Decided: Oct 16, 2015 after 101 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.
No later device cites it as a predicate yet.
0 of 8 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.

## Indications for use
rainbowTM Shade is a pre-sintered zirconia(Y-TZP) block for fabrication of single-tooth and bridgework restoration.

Source page: https://510kreport.com/device/K151844
Methodology: https://510kreport.com/methodology