# K202673: X-cera Pre-shaded Zirconia Blanks

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Xiangtong Co., Ltd.
- Decided: Dec 10, 2020 after 86 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: 8 generations back to K830955 (1983). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093560: Upcera Zirconia Blanks, Shenyang Upcera Co., Ltd. (2010) Summary page 4.

## Indications for use
X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist. All blanks are processed through dental laboratories or by dental professionals

Source page: https://510kreport.com/device/K202673
Methodology: https://510kreport.com/methodology