# K031326: Imagine Reflex

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Jun 17, 2003 after 53 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 K871808 (1987). 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)
- K871808: Duceram-Metal-Ceramic Dental Porcelain System, Degussa Dental, Inc. (1987) Summary page 1.

## Indications for use
Imagine Reflex is a dental ceramic that can be used by dental technicians to fabricate porcelain-fused-to-metal restorations. It is suitable for veneering dental alloys with a coefficient of thermal expansion [CTE (500°C): 13.8 15.1 x 10”K-’] and a solidus temperature that has to exceed 1000°C (I 830°F) as well as electroformed galvanogold. Imagine Reflex can be used for veneering inlays, partial crowns, single crowns, and bridges.

Source page: https://510kreport.com/device/K031326
Methodology: https://510kreport.com/methodology