# K161652: Diazir

- Pathway: 510(k) (Traditional)
- Applicant: Zxtgy (Beijing) Technology Co., Ltd.
- Decided: Nov 28, 2017 after 531 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
DIAZIR Zirconia Dental Ceramics are indicated for the use of artificial teeth production for either fixed or removable dentures, or for jacket crowns, facings, veneers as well as bridge up to three units.

Source page: https://510kreport.com/device/K161652
Methodology: https://510kreport.com/methodology