# K220960: BruxZir Opaque Coloring Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Jun 29, 2022 after 89 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.
1 later device descends from it; 1 cites it directly.
0 of 6 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.

## Most influential descendants
- K231347: BruxZir™ TintEFX Coloring Liquid (2023), 0 descendants of its own

## Indications for use
BruxZir™ Opaque Coloring Liquid is used for coloring pre-sintered zirconia structures.

Source page: https://510kreport.com/device/K220960
Methodology: https://510kreport.com/methodology