# K012841: Duo Pal 6, Order-NO.: 2154

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Edelmetalle GmbH & Co.
- Decided: Nov 20, 2001 after 89 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 K911669 (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)
- K911669: Cerapall 6, Metalor Dental USA Corp. (1991) Summary page 1.

## Indications for use
Duo Pal 6 is a palladium-gold ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Crowns Short span bridges Long span bridges Removable partials and can be used for Telescopic and milling work Duo Pal 6 can be veneered with suitable dental ceramics as well as with dental-composites.

Source page: https://510kreport.com/device/K012841
Methodology: https://510kreport.com/methodology