# K241579: DD Hybridlayer (multicolored zirconia)

- Pathway: 510(k) (Traditional)
- Applicant: Dental Direkt GmbH
- Decided: Sep 6, 2024 after 95 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). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 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 5.

## Indications for use
Dental Direkt zirconium dioxide milling blanks are intended for the fabrication of fixed restorations for long-term use.

Source page: https://510kreport.com/device/K241579
Methodology: https://510kreport.com/methodology