# K171585: LUXEN Zr, LUXEN Smile

- Pathway: 510(k) (Traditional)
- Applicant: Dentalmax Co., Ltd.
- Decided: Oct 31, 2018 after 518 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: 9 generations back to K830955 (1983). 25 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142987: DD Bio Z, DD Bio ZX (square), DD BioZX (square) color, Dental Direkt of Amerika UG (Haftungsbeschraenkt) (2015) Summary page 4.
- K150196: DD cubeX2, Dental Direkt GmbH (2015) Summary page 8.

## Most influential descendants
- K241151: Luxen 5G (2024), 1 descendant of its own
- K210097: Estar-Z (2021), 1 descendant of its own
- K262074: Any-Zircos (2026), 0 descendants of its own
- K242521: Estar-ZE (2024), 0 descendants of its own
- K221429: KDF Zirconia Disc (2022), 0 descendants of its own

## Indications for use
LUXEN Zr is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks. LUXEN Smile is indicated for the production of full ceramic crowns, onlays, 3-bridges and inlay bridges (anterior and molar).

Source page: https://510kreport.com/device/K171585
Methodology: https://510kreport.com/methodology