510(k) · Cleared
ClearedSimidur S2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wieland Dental + Technik GmbH & Co. KG · EJS Alloy, Other Noble Metal
Cleared on Mar 15, 2002 after a 52-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Mar 15, 2002
- Review
- 52 days
- Class
- Class II
- Product code
- EJS
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EJS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K040042 | FDA’s K040042 is Medisil Silicone Sheeting 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…: Fax: e-mail: Date of Summary: Trade name: Classification name: Product code: C.D.R section: Classification: Legally marketed equivalent device: 510(k) number: K 040042, Simidur S2 Wieland Dental + Technik GmbH & Co. KG Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0 Dr… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All EJS devicesEJS Alloy, Other Noble Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJS
FDA has decided no EJS device since 2007.
Median 510(k) review, days · EJS
Too few EJS 510(k)s in any year since 2007 to give a median.
Recalls per year · EJS
No recall names EJS since 2007.
Adverse event reports per year · EJS
No MAUDE report names EJS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020192: Simidur S2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020192
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026