# K012835: Porta Maximum, Model# 2066

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Edelmetalle GmbH & Co.
- Decided: Nov 1, 2001 after 70 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 K935973 (1994). 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)
- K935973: Argistar 72 (High Gold Platinum Silver Alloy for Both Low Fusing Porcelain and Crown and Bridge Application, Argen Precious Metals, Inc. (1994). Our OCR of the scanned summary read K955973, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words.

## Indications for use
Porta Maximum is a universal gold-based dental alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/ Onlays Partial crowns Crowns Short span bridges Long span bridges Removable partials and can be used for Telescopic and milling work Porta Maximum can be veneered with low-fusing dental ceramics with high expansion as well as with dental-composites.

Source page: https://510kreport.com/device/K012835
Methodology: https://510kreport.com/methodology