# K142987: DD Bio Z, DD Bio ZX (square), DD BioZX (square) color

- Pathway: 510(k) (Abbreviated)
- Applicant: Dental Direkt of Amerika UG (Haftungsbeschraenkt)
- Decided: Feb 11, 2015 after 118 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.
7 later devices descend from it; 2 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)
- K093748: DD Bio Z and DD Bio Z - Transpa, Dental Direkt of Amerika UG (Haftungsbeschraenkt) (2010) Summary page 5.

## 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
DD Bio Z-dental blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.

Source page: https://510kreport.com/device/K142987
Methodology: https://510kreport.com/methodology