# K240882: BruxZir® Esthetic

- Pathway: 510(k) (Special)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: May 1, 2024 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: 3 generations back to K060104 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213425: BruxZir Esthetic, Prismatik Dentalcraft, Inc. (2021). Our reading of the summary gave K231425, FDA’s number for Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) (Wuxi Jiajian Medical Instrument Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “BruxZir® Esthetic”. Summary page 6.

## 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/K240882
Methodology: https://510kreport.com/methodology