# K063511: Ceramill ZI

- Pathway: 510(k) (Traditional)
- Applicant: Amann Girrbach America, Inc.
- Decided: Feb 2, 2007 after 74 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: 2 generations back to K980986 (1998). 5 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053438: Glass Ceramics, 3M Espe AG Dental Products (2006) Summary page 1.
- K052130: Vita in-Ceram 2000 AL Cubes for Inlab, Models AL20/AL40, Vident (2005) Summary page 1.
- K061851: Zirkonzahn Ice, Zirkonzahn GmbH (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K032811: Cedia Vancomycin Assay, Microgenics Corp. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K171876: Ceramill Zolid HT+ white (2017), 1 descendant of its own

## Indications for use
Amann Girrbach America, Inc. Ceramill Zi blanks are used in the manufacture of dental prosthetics.

Source page: https://510kreport.com/device/K063511
Methodology: https://510kreport.com/methodology