510(k) Report

510(k) · Cleared

Cleared

Argistar 72 (High Gold Platinum Silver Alloy for Both Low Fusing Porcelain and Crown and Bridge Application

K935973510(k) TraditionalCleared Jan 28, 199446-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

Argen Precious Metals, Inc. · EJT Alloy, Gold-Based Noble Metal

Cleared on Jan 28, 1994 after a 46-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Jan 28, 1994
Review
46 days
Class
Class II
Product code
EJT
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared1990200020102020
  1. This deviceK935973 Argistar 72 (High Gold Platinum Silver Alloy for Both Low Fusing…Argen Precious Metals, Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK012835 Porta Maximum, Model# 2066Wieland Edelmetalle GmbH & Co. · 2001

Most influential descendants

Showing 1 of 1 · See all
  • K012835Porta Maximum, Model# 2066Wieland Edelmetalle GmbH & Co. · 2001 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935973Argistar 72 (High Gold Platinum Silver Alloy for Both Low Fusing Porcelain and…Argen Precious Metals, Inc.1994—
+1K012835Porta Maximum, Model# 2066Wieland Edelmetalle GmbH & Co.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K935973, 1994–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012835Porta Maximum, Model# 2066Wieland Edelmetalle GmbH & Co.20010

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?

  • Of its descendants, K012835 (Wieland Edelmetalle GmbH & Co., 2001) has gone furthest, with 0 descendants of its own.

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

2011: 12014: 12016: 12017: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—01
20150—00
20160—01
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Argen Precious Metals, Inc.

217 FDA decisions under this applicant name. See the company

  • K965216Argi-Satin or OPTI0-StarArgen Precious Metals, Inc. · 1997
  • K961352285 SLArgen Precious Metals, Inc. · 1996
  • K961211Argelite 52+Argen Precious Metals, Inc. · 1996
  • K961285Argedent 40(Gold-Palladium-Silver Alloy for Porcelain Application)Argen Precious Metals, Inc. · 1996
  • K954362Argistar 74Argen Precious Metals, Inc. · 1995

Recent decisions in EJT

The EJT category page

  • K052463Prometal HN86Prometal Technologies · 2005
  • K041378BIO 60Kodent, Inc. · 2004
  • K040672Porta ReflexWieland Dental + Technik GmbH & Co. KG · 2004
  • K040524Porta Solder 1090 WWieland Dental + Technik GmbH & Co. KG · 2004
  • K040043NDX-40 AlloyHeraeus Kulzer, Inc. · 2004

https://510kreport.com/device/K935973 · printed Nov 4, 2026

Cite this page

510(k) Report. “K935973: Argistar 72 (High Gold Platinum Silver Alloy for Both Low Fusing Porcelain and Crown and Bridge Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935973

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026