# K123545: Incoris Tzi

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Feb 1, 2013 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: 1 generation back to K060104 (2006). 1 ancestor in all.
2 later devices descend from it; 2 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)
- K060104: Prismatik Clinical Zirconia, Glidewell Laboratories (2006) Summary page 1.

## Most influential descendants
- K242462: CEREC Cercon 4D CAD/CAM Blocks (2024), 0 descendants of its own
- K151875: Pavati Zirconia (2015), 0 descendants of its own

## Indications for use
Classic and Speed.Sintering: Fully anatomic crowns and bridges in the posterior and anterior tooth region. Bridges with max. two pontics. Super Speed Sintering: Fully anatomic crowns.

Source page: https://510kreport.com/device/K123545
Methodology: https://510kreport.com/methodology