# K213570: Dental Zirconia Ceramic

- Pathway: 510(k) (Traditional)
- Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.
- Decided: Jan 7, 2022 after 58 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)
- K141724: Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, Liaoning Upcera Co., Ltd. (2014) Summary page 4.

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

Source page: https://510kreport.com/device/K213570
Methodology: https://510kreport.com/methodology