# K123664: Incoris ZI

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Apr 8, 2013 after 131 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 K062509 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062509: Incoris ZI, Sirona Dental Systems GmbH (2006) Summary page 1.

## Indications for use
Classic sintering * Framework and reduced crowns in the anterior and posterior tooth region * Bridge frameworks in the anterior and posterior tooth region with max. 2 panties o Crown caps in the anterior and posterior region * Cone and telescoping crowns Sneed sinterino * Framework and reduced crowns in the anterior and posterior toot region * Bridge frameworks in the anterior and posterior tooth region with max. 2 pontics and up to 9 units " Crown caps in the anterior and posterior region " Cone and telescoping crowns Suner snleed sintering *Framework and reduced crowns with a maximum wall-thickness of 2 mm

Source page: https://510kreport.com/device/K123664
Methodology: https://510kreport.com/methodology