# K062509: Incoris ZI

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Sep 12, 2006 after 15 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K190569: Shaders ZR (2019), 0 descendants of its own
- K151875: Pavati Zirconia (2015), 0 descendants of its own
- K123664: Incoris ZI (2013), 0 descendants of its own

## Indications for use
inCoris ZI are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crowns and bridges. Substructures of inCoris ZI are machined using the CEREC 2, CEREC 3 and inLab CAD/CAM systems.

Source page: https://510kreport.com/device/K062509
Methodology: https://510kreport.com/methodology