# K240574: BruxZir® Radiant

- Pathway: 510(k) (Special)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Mar 20, 2024 after 19 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 K150872 (2015). 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)
- K150872: BruxZir Anterior Milling Blanks, Prismatik Dentalcraft, Inc. (2015) Summary page 4.

## 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. Contraindication: This device is contraindicated for dental restorations greater than 3-units in length.

Source page: https://510kreport.com/device/K240574
Methodology: https://510kreport.com/methodology