# K061851: Zirkonzahn Ice

- Pathway: 510(k) (Traditional)
- Applicant: Zirkonzahn GmbH
- Decided: Sep 29, 2006 after 91 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
No predicates in its family tree.
19 later devices descend from it; 6 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063511: Ceramill ZI (2007), 12 descendants of its own
- K092513: Rainbow Block (2009), 5 descendants of its own
- K152383: Ceramill Zolid FX (2015), 3 descendants of its own
- K151842: Rainbow Shine (2016), 2 descendants of its own
- K170050: Z-CAD smile (2018), 1 descendant of its own

## Indications for use
Metal free single posterior crowns, multiple unit anterior crowns/bridges, inlays, onlays bonded dental restorations.

Source page: https://510kreport.com/device/K061851
Methodology: https://510kreport.com/methodology