# K031264: Porta Pressover

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Jun 12, 2003 after 52 days
- Product code: EJT (Alloy, Gold-Based Noble Metal)
- Device class: 2
- Regulation: 21 CFR 872.3060
- 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 K911541 (1991). 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)
- K911541: Pontor 4 CF, Metalor Dental USA Corp. (1991) Summary page 1.

## Indications for use
Porta Pressover is a gold-silver-palladium alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing InlayslOnlays Crowns Short span bridges and can be used for Telescopic and milling work Porta PressOver can be utilized as a conventional casting alloy, in which it can be veneered with dental composites, as well as a ceramic alloy, which has to be veneered (pressed over) by the IMAGINE h.e. Press ceramic of Wieland Dental + Technik GmbH & Co. KG.

Source page: https://510kreport.com/device/K031264
Methodology: https://510kreport.com/methodology