# K193588: DD Contrast

- Pathway: 510(k) (Traditional)
- Applicant: Dental Direkt GmbH
- Decided: Apr 16, 2020 after 115 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: 4 generations back to K024250 (2003). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111743: The Insync Ceramic System, Jensen Industries, Inc. (2011) Summary page 5.

## Most influential descendants
- K231264: Easy On Universal Glaze & Stain (2023), 0 descendants of its own

## Indications for use
The DD contrast® veneering ceramics system is suitable for the esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions made of zirconium dioxide or lithium disilicate.

Source page: https://510kreport.com/device/K193588
Methodology: https://510kreport.com/methodology