# K163238: Eclipse Kiss Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: Ams
- Decided: May 4, 2017 after 167 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)
- K150196: DD cubeX2, Dental Direkt GmbH (2015) Summary page 5.

## Indications for use
This device is a ceramic-based material that is used for prefabricated and patient-matched dental restorations such as inlays, artificial teeth, crowns, or bridges (up to maximum three-unit bridges) and processed by dental CAD/CAM.

Source page: https://510kreport.com/device/K163238
Methodology: https://510kreport.com/methodology