# K241151: Luxen 5G

- Pathway: 510(k) (Traditional)
- Applicant: Dentalmax Co., Ltd.
- Decided: Sep 30, 2024 after 158 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: 10 generations back to K830955 (1983). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171585: LUXEN Zr, LUXEN Smile, Dentalmax Co., Ltd. (2018) Summary page 5.

## Most influential descendants
- K262074: Any-Zircos (2026), 0 descendants of its own

## Indications for use
LUXEN 5G is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks.

Source page: https://510kreport.com/device/K241151
Methodology: https://510kreport.com/methodology