# K200131: BruxZir Steel

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Jun 10, 2020 after 141 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 K123680 (2013). 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)
- K173769: DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid, Dmax Co., Ltd. (2018) Summary page 5.

## Indications for use
BruxZir Steel™ can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading and to produce a strong prosthesis with a porcelain-like finish. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.

Source page: https://510kreport.com/device/K200131
Methodology: https://510kreport.com/methodology