# K140836: Zibone Zirconia Blocks

- Pathway: 510(k) (Traditional)
- Applicant: Coho Technology Co., Ltd.
- Decided: Jun 17, 2015 after 441 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: 1 generation back to K100145 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100145: A&E Zirconia Blanks Model EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06, A&E Bioceramic Co., Ltd. (2010) Summary page 4.

## Indications for use
“Zibone Zirconia Blocks” are intended for CAD/CAM fabrication of full ceramic dental restorations such as copings, crowns, inlays, onlays, veneers, and bridges of 3 or less units.

Source page: https://510kreport.com/device/K140836
Methodology: https://510kreport.com/methodology