# K153767: X-cera Zirconia Blanks

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Xiangtong Photoelectricity Technology Co., Ltd.
- Decided: Mar 29, 2016 after 90 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: 9 generations back to K830955 (1983). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111291: Aidite Zirconia Dental Ceramics, Qinhuangdao Aidite High-Technical Ceramics Co, Ltd. (2011) Summary page 4.

## Indications for use
X-cera Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Source page: https://510kreport.com/device/K153767
Methodology: https://510kreport.com/methodology