# K100145: A&E Zirconia Blanks Model EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06

- Pathway: 510(k) (Abbreviated)
- Applicant: A&E Bioceramic Co., Ltd.
- Decided: Apr 13, 2010 after 84 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K140836: Zibone Zirconia Blocks (2015), 0 descendants of its own

## Indications for use
"A&E Zirconia Blanks" are pre-sintered metal-free ZrO2 ceramic blanks (Y-TZP). They are specifically designed for fabrication of sub-frames for the construction of dental prostihetics (e.g. crowns and bridges restorations etc.) with the aid of manual copy-milling machines and CAD/CAM systems.

Source page: https://510kreport.com/device/K100145
Methodology: https://510kreport.com/methodology