# K183569: DD cube ONE ML

- Pathway: 510(k) (Special)
- Applicant: Dental Direkt GmbH
- Decided: Feb 14, 2019 after 55 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: 1 generation back to K170885 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170885: DD cubeX2 HS, Dental Direkt GmbH (2017) Summary page 4.

## Indications for use
DD cube ONE ML dental zirconia blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both, anterior and posterior bridges.

Source page: https://510kreport.com/device/K183569
Methodology: https://510kreport.com/methodology