# K220816: BruxZir NOW

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Aug 2, 2022 after 134 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: 10 generations back to K830955 (1983). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203590: Perfit FS Dental Zirconia Fully Sintered Block, Vatech Acucera, Inc. (2021) Summary page 4.

## Most influential descendants
- K252446: BruxZir® NOW (2025), 0 descendants of its own
- K250223: BruxZir® Esthetic NOW (2025), 0 descendants of its own

## Indications for use
BruxZir® NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

Source page: https://510kreport.com/device/K220816
Methodology: https://510kreport.com/methodology