# K192262: Dental  Zirconia  Blocks

- Pathway: 510(k) (Traditional)
- Applicant: De Corematrix Co., Ltd.
- Decided: May 29, 2020 after 282 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: 10 generations back to K830955 (1983). 19 ancestors in all.
3 later devices descend from it; 3 cite 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)
- K182068: Erran Dental Zirconia, Hangzhou Erran Technology Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- 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
Dental Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers. All Blocks are processed through dental laboratories or by dental professionals.

Source page: https://510kreport.com/device/K192262
Methodology: https://510kreport.com/methodology