# K233016: Dental Glass Ceramics

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Yurucheng Dental Materials Co., Ltd.
- Decided: Dec 21, 2023 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: 3 generations back to K051705 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202952: Amber Mill Q Series & Amber Mill Direct Series, Hass Corp. (2021) Summary page 5.

## Indications for use
Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays, onlays, veneer, partial crowns and crowns.

Source page: https://510kreport.com/device/K233016
Methodology: https://510kreport.com/methodology