510(k) · Cleared
ClearedSimidur S1S
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 as substantially equivalent to K891320 (Argen Precious Metals, Inc., 1989) after a 52-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Mar 15, 2002
- Review
- 52 days
- Class
- Class II
- Product code
- EJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891320 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK891320 Argelite 58P (Dental Alloy)Argen Precious Metals, Inc. · 1989
- This deviceK020195 Simidur S1SWieland Dental + Technik GmbH & Co. KG · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891320 | Argelite 58P (Dental Alloy) | Argen Precious Metals, Inc. | 1989 | — |
| 0 (this device) | K020195 | Simidur S1S | Wieland Dental + Technik GmbH & Co. KG | 2002 | — |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K891320 | Argelite 58P (Dental Alloy)Summary page 1…49-7231-3705-219 +49-7231-357959 [email protected] 2001-12-14 Simidur S1S Alloy, precious metal, for clinical use EJS 872.3060 Class | Argelite 58P K 891320 Device description Simidur $1S is a palladium-base ceramic alloy (56,0% Palladium), intended for dental technicians to fabricat… | 1989 |
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.
What does this lineage say?
- Its one ancestor has no 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 S1S 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
Removable partials
and can be used for
. Telescopic and milling work
Simidur S1S 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/K020195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020195: Simidur S1S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020195
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026