# K123615: Iris - High Strength Glass Ceramic

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Feb 22, 2013 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
Longest line of descent: 1 generation back to K051705 (2005). 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)
- K051705: Ips E.Max Cad/Ips E.Max Zircad, Ivoclar Vivadent, Inc. (2005) Summary page 1.

## Indications for use
IRIS - High Strength Glass Ceramic is a system of precrystallized and/or fully crystallized zirconia reinforced lithium silicate glass ceramics and veneering ceramics processed through CAD-CAM techniques for the fabrication of: Single unit dental restorations, for example all-ceramic crowns, inlays, onlays and veneers. IRIS can be used as a substructure which is then veneered with IRIS veneering ceramic or can be used for full-contour application (without veneering) as well.

Source page: https://510kreport.com/device/K123615
Methodology: https://510kreport.com/methodology