# K241316: Zirconia Block

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Hualian Special Ceramics Co., Ltd.
- Decided: Jul 9, 2024 after 60 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 K022996 (2002). 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)
- K222626: Dental Zirconia Ceramic, Aidite (Qinhuangdao) Technology Co., Ltd. (2022) Summary page 6.

## Indications for use
HT, HT-C, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML: used to make the crown, bridge, inlay, veneer of the all-porcelain restoration. UT, UT-C, UT-ML and 3D-PRO: used to make the crown, maximum 3-unit bridge, inlay, veneer of the all-porcelain restoration.

Source page: https://510kreport.com/device/K241316
Methodology: https://510kreport.com/methodology