# K231940: BruxZir® NOW SRC

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: May 15, 2024 after 320 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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 K132746 (2014). 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)
- K181869: On1 Universal Abutment, Nobel Biocare AB (2018) Summary page 5.

## Indications for use
BruxZir® NOW SRC is a pre-manufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. BruxZir® NOW SRC consists of two major parts. Specifically, the pre-cemented titanium abutment and zirconia superstructure components make up a two-piece abutment. All digitally designed CAD/CAM customizations for BruxZir® NOW SRC are only intended to be designed and manufactured according to digital dentistry workflow, which incorporates multiple components of the digital dentistry workflow including scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

Source page: https://510kreport.com/device/K231940
Methodology: https://510kreport.com/methodology