# K233125: Zirconia Block

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Ivista Medical Devices Co., Ltd.
- Decided: Jan 12, 2024 after 107 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: 11 generations back to K830955 (1983). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192262: Dental  Zirconia  Blocks, De Corematrix Co., Ltd. (2020) Summary page 5.

## Indications for use
Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures,for jacket facing,veneers.All Blocks are processed through dental laboratories or by dental professionals.

Source page: https://510kreport.com/device/K233125
Methodology: https://510kreport.com/methodology