# K222626: Dental Zirconia Ceramic

- Pathway: 510(k) (Traditional)
- Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.
- Decided: Dec 6, 2022 after 97 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 K022996 (2002). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183304: Prettau, ICE, Z-White zirconia blanks, Zirkonzahn Srl (2019) Summary page 4.

## Most influential descendants
- K250811: Dental Zirconia Ceramic (2025), 0 descendants of its own
- K242458: ArgenZ MTZ (2024), 0 descendants of its own
- K241316: Zirconia Block (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K222626
Methodology: https://510kreport.com/methodology