# K220369: Esthetic Colorant

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Sep 23, 2022 after 227 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 K011394 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190518: Color Liquid, Vita Liquid, Zirkonzahn Srl (2019) Summary page 4.

## Indications for use
Esthetic Colorant is used for coloring pre-sintered zirconia structures for the fabrication of all-ceramic restorations.

Source page: https://510kreport.com/device/K220369
Methodology: https://510kreport.com/methodology