# K073314: Heany Industries Inc Dental Xirconia

- Pathway: 510(k) (Traditional)
- Applicant: Heany Industries, Inc.
- Decided: Feb 21, 2008 after 87 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 K011394 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011394: Lava Frame, Lava Frame Shade, Lava Ceram, Espe Dental AG (2001)
- K051705: Ips E.Max Cad/Ips E.Max Zircad, Ivoclar Vivadent, Inc. (2005). Our reading of the summary gave K041705, FDA’s number for Resolution Thrombectomy System, Model EV-2 (Omnisonics Medical Technologies). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “IPS E.MAX CAD/IPS E.MAX ZIRCAD”.

## Cited in the summary but kept off the family tree
- K060389: Confidose IM Auto-Injector, Pharma-Pen, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K150056: Luxisse+ (2015), 0 descendants of its own

## Indications for use
Heany Industries Inc. Dental Zirconia is non implantable material intended for CAD/CAM fabrication of core material used in all-ceramic dental restorations. The material is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Source page: https://510kreport.com/device/K073314
Methodology: https://510kreport.com/methodology