# K012828: Porta SMK 82, Model 2032

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Edelmetalle GmbH & Co.
- Decided: Nov 1, 2001 after 70 days
- Product code: EJS (Alloy, Other 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 K921419 (1992). 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)
- K921419: Deva Plus, Degussa AG (1992) Summary page 1.

## Indications for use
Porta SMK 82 is a gold-palladium ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Partial crowns Crowns Short span bridges Long span bridges Removable partials and can be used for Telescopic and milling work Porta SMK 82 can be veneered with suitable dental ceramics as well as with dental-composites.

Source page: https://510kreport.com/device/K012828
Methodology: https://510kreport.com/methodology