# K023395: Portadur P2

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Dec 11, 2002 after 63 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 K911539 (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)
- K911539: Aurofluid 3, Metalor Dental USA Corp. (1991) Summary page 1.

## Indications for use
Portadur P2 is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/ Onlays Crowns Short span bridges Long span bridges Removable partials and can be used for Telescopic and milling work In addition Portadur P2, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of identical or comparable alloys are joined to form dental restorations.

Source page: https://510kreport.com/device/K023395
Methodology: https://510kreport.com/methodology