# K150056: Luxisse+

- Pathway: 510(k) (Traditional)
- Applicant: Heany Industries, Inc.
- Decided: May 6, 2015 after 114 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: 2 generations back to K011394 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073314: Heany Industries Inc Dental Xirconia, Heany Industries, Inc. (2008) Summary page 4.

## Indications for use
Heany Industries, Inc. “Luxisse +” is non-implantable, machinable Zirconia material intended for CAD/CAM fabrication of all ceramic dental restorations. The material is used for the manufacturing of inlays, onlays, veneers, single unit anterior and posterior crowns, and three unit anterior bridges.

Source page: https://510kreport.com/device/K150056
Methodology: https://510kreport.com/methodology