# K040859: Heraceram Press

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: May 20, 2004 after 48 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
HeraCeram Press dental ceramic compound is intended for use with the HeraCeram. It can be used for full ceramic restorations with the common layering technique as well as the staining technique. Applications: Veneers, Inlays, Onlays and Crowns.

Source page: https://510kreport.com/device/K040859
Methodology: https://510kreport.com/methodology