# K230259: Soreal Press, Soreal CAD

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Up3D Technology Co., Ltd.
- Decided: May 25, 2023 after 114 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 K070772 (2007). 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)
- K192231: Dental Glass Ceramics Blocks, Aidite (Qinhuangdao) Technology Co., Ltd. (2020) Summary page 4.

## Indications for use
Soreal Press is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique. Soreal CAD is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the CAD/CAM system.

Source page: https://510kreport.com/device/K230259
Methodology: https://510kreport.com/methodology