# K214005: Zirconia Dental Ceramics

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Yurucheng Dental Materials Co., Ltd.
- Decided: Feb 18, 2022 after 59 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: 11 generations back to K830955 (1983). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192262: Dental  Zirconia  Blocks, De Corematrix Co., Ltd. (2020) Summary page 4.

## Indications for use
Zirconia Dental Ceramics are intended for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

Source page: https://510kreport.com/device/K214005
Methodology: https://510kreport.com/methodology