# K231347: BruxZir™ TintEFX Coloring Liquid

- Pathway: 510(k) (Special)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Jun 9, 2023 after 31 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: 5 generations back to K011394 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220960: BruxZir Opaque Coloring Liquid, Prismatik Dentalcraft, Inc. (2022) Summary page 4.

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

Source page: https://510kreport.com/device/K231347
Methodology: https://510kreport.com/methodology