# K182068: Erran Dental Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Erran Technology Co., Ltd.
- Decided: Dec 13, 2018 after 134 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.
4 later devices descend from it; 1 cites it directly.
0 of 23 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 5.

## Most influential descendants
- K192262: Dental  Zirconia  Blocks (2020), 3 descendants of its own
- K233125: Zirconia Block (2024), 0 descendants of its own
- K221429: KDF Zirconia Disc (2022), 0 descendants of its own
- K214005: Zirconia Dental Ceramics (2022), 0 descendants of its own

## Indications for use
Erran Dental Zirconia are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers.

Source page: https://510kreport.com/device/K182068
Methodology: https://510kreport.com/methodology