# K092513: Rainbow Block

- Pathway: 510(k) (Abbreviated)
- Applicant: Genoss Co., Ltd.
- Decided: Oct 9, 2009 after 53 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: 3 generations back to K980986 (1998). 6 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061851: Zirkonzahn Ice, Zirkonzahn GmbH (2006) Summary page 1.
- K063511: Ceramill ZI, Amann Girrbach America, Inc. (2007) Summary page 1.

## Most influential descendants
- K151842: Rainbow Shine (2016), 2 descendants of its own
- 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
- K151723: Rainbow Trans (2015), 0 descendants of its own
- K151844: Rainbow Shade (2015), 0 descendants of its own

## Indications for use
Rainbow Block 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/K092513
Methodology: https://510kreport.com/methodology