# K012843: Portadur P 2, Model #2031

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Edelmetalle GmbH & Co.
- Decided: Nov 2, 2001 after 71 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 P 2 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

Source page: https://510kreport.com/device/K012843
Methodology: https://510kreport.com/methodology