# K213425: BruxZir Esthetic

- Pathway: 510(k) (Special)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Nov 17, 2021 after 27 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: 2 generations back to K060104 (2006). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130924: Bruxzir Shaded, Prismatik Dentalcraft, Inc. (2013) Summary page 5.

## Most influential descendants
- K233064: Copra Supreme (2024), 0 descendants of its own
- K240882: BruxZir® Esthetic (2024), 0 descendants of its own

## Indications for use
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

Source page: https://510kreport.com/device/K213425
Methodology: https://510kreport.com/methodology