# K192535: Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: Qinhuangdao Audental Metal Technology Co., Ltd.
- Decided: Jan 31, 2020 after 137 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: 4 generations back to K011394 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172761: New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded), Shanghai New Century Dental Materials Co., Ltd. (2017) Summary page 6.

## Indications for use
The Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.

Source page: https://510kreport.com/device/K192535
Methodology: https://510kreport.com/methodology