# K020192: Simidur S2

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Mar 15, 2002 after 52 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K040042: Medisil Silicone Sheeting, Medisil Corporation (2004). Our OCR of the scanned summary read K040042, which FDA decided on Apr 1, 2004, after this device was decided (Mar 15, 2002), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1.

## Indications for use
Simidur S2 is a palladium-base 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 o Removable partials and can be used for . Telescopic and milling work Simidur S2 can be veneered with suitable dental ceramics as well as with dental-composites.

Source page: https://510kreport.com/device/K020192
Methodology: https://510kreport.com/methodology