# K130924: Bruxzir Shaded

- Pathway: 510(k) (Special)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: May 16, 2013 after 43 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K060104 (2006). 1 ancestor in all.
12 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060104: Prismatik Clinical Zirconia, Glidewell Laboratories (2006) Summary page 1.

## Most influential descendants
- K143330: BruxZir Anterior (2014), 6 descendants of its own
- K213425: BruxZir Esthetic (2021), 2 descendants of its own
- K162888: Cercon (2017), 1 descendant of its own
- K161219: Zmaxx T Series (2017), 1 descendant of its own
- K254283: BruxZir® Shaded 16 PLUS (2026), 0 descendants of its own

## Recalls of this device
- Aug 15, 2016 · Class II · Z-2897-2016: Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly i

## 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/K130924
Methodology: https://510kreport.com/methodology