# K141162: All-Ceramic Zirconia Block

- Pathway: 510(k) (Abbreviated)
- Applicant: Rizhao Huge Dental Industry Co., Ltd.
- Decided: Aug 27, 2014 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: 9 generations back to K830955 (1983). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111291: Aidite Zirconia Dental Ceramics, Qinhuangdao Aidite High-Technical Ceramics Co, Ltd. (2011) Summary page 7.

## Indications for use
The product is indicated for the production of artificial tecth in fixed or removable dentures, or for jacket crowns. facings, and veneers.

Source page: https://510kreport.com/device/K141162
Methodology: https://510kreport.com/methodology