# K020774: Imagine H.E. Press Design-Ceramic

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: May 22, 2002 after 72 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
IMAGINE h.e. Press Design-Ceramic is a dental porcelain that can be used by dental technicians for the fabrication of metal free all-ceramic dental restorations. IMAGINE h.e. Press Design-Ceramic is intended for manufacturing: Metall-free single unit restorations in the anterior region and posterior region up to the second premolar, 0, MO, or MOD inlays and Onlays, and veneers

Source page: https://510kreport.com/device/K020774
Methodology: https://510kreport.com/methodology