# K254283: BruxZir® Shaded 16 PLUS

- Pathway: 510(k) (Special)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Jan 30, 2026 after 30 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.
No later device cites it as a predicate yet.
0 of 3 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.

## 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/K254283
Methodology: https://510kreport.com/methodology