# K201492: Non-Sterile Zirconia Block

- Pathway: 510(k) (Traditional)
- Applicant: Bioden Co., Ltd.
- Decided: Mar 10, 2021 after 279 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: 12 generations back to K830955 (1983). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190112: Non-Sterile Zirconia Block, Fine Advanced Compound Co., Ltd. (2019) Summary page 4.

## Indications for use
Non-Sterile Zirconia Block (Model: Zircos-E ACE) is indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Source page: https://510kreport.com/device/K201492
Methodology: https://510kreport.com/methodology