# K223194: Glass Ceramic

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Xiangtong Co., Ltd.
- Decided: Feb 10, 2023 after 120 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: 3 generations back to K070772 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141727: Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and UP. Cad Series), Liaoning Upcera Co., Ltd. (2014) Summary page 5.

## Indications for use
Glass Ceramic are indicated for fabricating all-ceramic restorations such as veneers, inlays, onlays, crowns, 2-unit anterior bridges, using the CAD/CAM system.

Source page: https://510kreport.com/device/K223194
Methodology: https://510kreport.com/methodology