510(k) · Cleared

Cleared

Simidur KF Plus

K020194510(k) TraditionalCleared Mar 15, 200252-day reviewClass II21 CFR 872.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wieland Dental + Technik GmbH & Co. KG · EJS Alloy, Other Noble Metal

Cleared on Mar 15, 2002 as substantially equivalent to K913704 (Argen Precious Metals, Inc., 1991) after a 52-day review. Its family tree reaches back 1 generation to 1991.

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 K913704 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK913704 Argebond 80Argen Precious Metals, Inc. · 1991
This deviceK020194 Simidur KF PlusWieland 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	K913704	Argebond 80	Argen Precious Metals, Inc.	1991	—
0 (this device)	K020194	Simidur KF Plus	Wieland Dental + Technik GmbH & Co. KG	2002	—

FIG. 1 — Lineage of K020194, 1991–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K913704	Argebond 80 Summary page 1 …31~-3705-219 +49-7231-357959 [email protected] 2001-12-14 Simidur KF plus Alloy, precious metal, for clinical use EJS 872.3060 Class \|\| Argebond 80 K 913704 Device description Simidur KF plus is a palladium-base ceramic alioy (79,7% Palladium), intended for dental technicians to fabr…	Argen Precious Metals, Inc.	1991	—

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 devices

EJS 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	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

Simidur KF plus 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 KF plus 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/K020194 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020194: Simidur KF Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020194

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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