# K191903: BruxZir GT (Gum Tissue) Color

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Nov 22, 2019 after 129 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: 1 generation back to K061851 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061851: Zirkonzahn Ice, Zirkonzahn GmbH (2006) Summary page 5.

## Indications for use
BruxZir GT (Gum Tissue) Color™ is indicated for metal free single posterior crowns, multiple unit anterior crowns/bridges including full and partial arches, bonded restorations.

Source page: https://510kreport.com/device/K191903
Methodology: https://510kreport.com/methodology