# K231142: Temporis, Irix Plus

- Pathway: 510(k) (Traditional)
- Applicant: Dws S.R.L.
- Decided: Apr 25, 2024 after 370 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K042819 (2004). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202846: Tera Harz, Graphy, Inc. (2021) Summary page 5.

## Indications for use
Temporis and Irix Plus are light-curing 3D-printing materials intended for fabricating indirect restorative for both anterior and posterior restorations, such as inlays, onlays, veneers, anterior or posterior crowns and bridges. Temporis is used for fabricating temporary dental restorations, Irix Plus is used for fabricating permanent dental restorations.

Source page: https://510kreport.com/device/K231142
Methodology: https://510kreport.com/methodology