510(k) Report

510(k) · Cleared

Cleared

Critertion, Model #1067511

K021741510(k) AbbreviatedCleared Jun 26, 200229-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

Sterngold · EJT Alloy, Gold-Based Noble Metal

Cleared on Jun 26, 2002 as substantially equivalent to K944679 (J.F. Jelenko & Co., Inc., 1994) and 2 other predicates after a 29-day review. Its family tree reaches back 1 generation to 1989.

Decided
Jun 26, 2002
Review
29 days
Class
Class II
Product code
EJT
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K892335 (1989). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1994: 1 other ancestorK892335 · Argedent 74 Dental Alloy for Porcelain Appli. · Argen Precious Metals, Inc. · 19891985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K892335 · Argedent 74 Dental Alloy for Porcelain Appli. · Argen Precious Metals, Inc. · 19890
  1. Root · 1 generation backK892335 Argedent 74 Dental Alloy for Porcelain Appli.Argen Precious Metals, Inc. · 1989
  2. This deviceK021741 Critertion, Model #1067511Sterngold · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K892335Argedent 74 Dental Alloy for Porcelain Appli.Argen Precious Metals, Inc.1989—
0 (this device)K021741Critertion, Model #1067511Sterngold2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199910
FIG. 1 — Lineage of K021741, 1989–2002Source: 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), 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
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What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K944679JEL 96
Summary page 1
…ation is Class Predicate Devices: Alloy Name 510(k) Manufactured By Je196 (k) 944679 Jelenko Argedent 74 &) 892335 Argen V-Supra Plus…
J.F. Jelenko & Co., Inc.1994—
*K892335Argedent 74 Dental Alloy for Porcelain Appli.
Summary page 1
…510(k) Manufactured By Je196 (k) 944679 Jelenko Argedent 74 &) 892335 Argen V-Supra Plus (k) 993508 Metalor Product Description: Crit…
Argen Precious Metals, Inc.1989—
*K993508V-Supra Plus, Alloy NO. 5025
Summary page 1
…(k) 944679 Jelenko Argedent 74 &) 892335 Argen V-Supra Plus (k) 993508 Metalor Product Description: Criterion is a White Porcelain Dental Alloy. Indications for Use: Precious all…
Metalor Dental USA Corp.1999—

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?

  • None of the 3 ancestors has a 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

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—

What is it indicated for?

Precious Alloy for use in dental restorations where porcelain application is indicated.

Indications for use as stated in the FDA summary.

More from Sterngold

12 FDA decisions under this applicant name. See the company

  • K092434Sterngold 2.2MM Angles Micro Era Dental Implant SystemSterngold · 2009
  • K041271Sterngold 3.25 Era Dental Implant SystemSterngold · 2004
  • K023580Sterngold Acid Etch Dental Implant SystemSterngold · 2003
  • K022252Sterngold 1, Model 1127781Sterngold · 2002
  • K021045Era ImplantSterngold · 2002

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/K021741 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021741: Critertion, Model #1067511.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021741

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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