# K150196: DD cubeX2

- Pathway: 510(k) (Special)
- Applicant: Dental Direkt GmbH
- Decided: Mar 26, 2015 after 56 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: 8 generations back to K830955 (1983). 23 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093748: DD Bio Z and DD Bio Z - Transpa, Dental Direkt of Amerika UG (Haftungsbeschraenkt) (2010) Summary page 4.

## Most influential descendants
- K171585: LUXEN Zr, LUXEN Smile (2018), 5 descendants of its own
- 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

## Indications for use
Dental blanks made from DD cubeX2 are indicated for crowns, multi-unit bridges (up to a maximum of 3 elements) and inlay bridges. Applications include both, anterior and posterior bridges.

Source page: https://510kreport.com/device/K150196
Methodology: https://510kreport.com/methodology