510(k) · Cleared

Cleared

Porta Optimum Solder 900

K022468510(k) TraditionalCleared Sep 17, 200253-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 · EJT Alloy, Gold-Based Noble Metal

Cleared on Sep 17, 2002 as substantially equivalent to K943838 (Argen Precious Metals, Inc., 1994) after a 53-day review. Its family tree reaches back 1 generation to 1994.

Decided: Sep 17, 2002
Review: 53 days
Class: Class II
Product code: EJT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K943838 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK943838 Argesol #760Argen Precious Metals, Inc. · 1994
This deviceK022468 Porta Optimum Solder 900Wieland 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	K943838	Argesol #760	Argen Precious Metals, Inc.	1994	—
0 (this device)	K022468	Porta Optimum Solder 900	Wieland Dental + Technik GmbH & Co. KG	2002	—

FIG. 1 — Lineage of K022468, 1994–2002Source: 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 EJT? 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K943838	Argesol #760 Summary page 1 …EJT C.D.R section: 872.3060 Classification: Class II Legally marketed equivalent device: Argesol#760 510(k) number: K 943838 Device description Porta Optimum Solder 900 is a dental brazing alloy, that can be used by dental technicians to fabricate d…	Argen Precious Metals, Inc.	1994	—

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 EJT devices

EJT Alloy, Gold-Based Noble Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EJT

FDA has decided no EJT device since 2007.

Median 510(k) review, days · EJT

Too few EJT 510(k)s in any year since 2007 to give a median.

Recalls per year · EJT

No recall names EJT since 2007.

Adverse event reports per year · EJT

1in 2017

2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code EJT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	1
2012	—	0
2013	—	0
2014	—	1
2015	—	0
2016	—	1
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

Porta Optimum Solder 900 is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration.

It should be used only together with recommended dental alloys with suitable melting ranges, compositions and coefficients of thermal expansion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022468 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022468: Porta Optimum Solder 900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022468

Report an extraction error

Are you the manufacturer?

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