# K230262: BruxZir™ Incisal Coloring Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: May 16, 2023 after 105 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 K011394 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182833: ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer, The Argen Corporation (2019) Summary page 4.

## Indications for use
BruxZir® Incisal Coloring Liquid is intended to be used by trained dental technicians as an accessory for shading BruxZir® Shaded 16 PLUS and BruxZir® Esthetic all zirconia, monolithic restorations for anterior and posterior dental prosthetics.

Source page: https://510kreport.com/device/K230262
Methodology: https://510kreport.com/methodology