# K012156: Imagine H.E.

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Edelmetalle GmbH & Co.
- Decided: Aug 16, 2001 after 36 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 K931808 (1993). 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)
- K931808: Duceragold, Duceratin, Degussa AG (1993) Summary page 1.

## Indications for use
imagine h.e. is a dental porcelain that is used by dental technicians to fabricate porcelain fused to metal or to press-ceramic restorations. It is suitable for veneering alloys with a high coefficient of thermal expansion [CTE(@25 - 500°C): 16.1-16.7 x 10°K], electroformed restorations, and heat-pressed ceramic frameworks made of the Imagine h.e. Press-Ceramic. Imagine h.e. can be used for veneering of inlays, partial crowns, crowns, and bridges.

Source page: https://510kreport.com/device/K012156
Methodology: https://510kreport.com/methodology