510(k) Report

510(k) · Cleared

Cleared

Sterngold 66, Model #1180230

K021367510(k) AbbreviatedCleared May 16, 200216-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 · EJS Alloy, Other Noble Metal

Cleared on May 16, 2002 as substantially equivalent to K923714 (J.F. Jelenko & Co., Inc., 1993) and 2 other predicates after a 16-day review. Its family tree reaches back 1 generation to 1988.

Decided
May 16, 2002
Review
16 days
Class
Class II
Product code
EJS
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K883036 (1988). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 1 other ancestor1989: 1 other ancestorK883036 · Palliag NF Iii · Degussa Dental, Inc. · 19881985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K883036 · Palliag NF Iii · Degussa Dental, Inc. · 19880
  1. Root · 1 generation backK883036 Palliag NF IiiDegussa Dental, Inc. · 1988
  2. This deviceK021367 Sterngold 66, Model #1180230Sterngold · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K883036Palliag NF IiiDegussa Dental, Inc.1988—
0 (this device)K021367Sterngold 66, Model #1180230Sterngold2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199310
FIG. 1 — Lineage of K021367, 1988–2002Source: 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 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? (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
*K923714Symphony
Summary page 1
…to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class I1. - Predicate Devices: Alloy Name 510(k) Manufactured By Symphony (k) 923714 Jelenko | Select White (k) 895070 Leach & Dillon Palliag NF 1II (k) 883036 Degussa Dental Product Description: v Sterngold 66 i…
J.F. Jelenko & Co., Inc.1993—
*K895070Select White
Summary page 1
…, Drug, and Cosmetic Act, the device classification is Class I1. - Predicate Devices: Alloy Name 510(k) Manufactured By Symphony (k) 923714 Jelenko | Select White (k) 895070 Leach & Dillon Palliag NF 1II (k) 883036 Degussa Dental Product Description: v Sterngold 66 is a White Crown and Bridge Alloy.…
Leach and Dillon Co., Inc.1989—
*K883036Palliag NF Iii
Summary page 1
…sification is Class I1. - Predicate Devices: Alloy Name 510(k) Manufactured By Symphony (k) 923714 Jelenko | Select White (k) 895070 Leach & Dillon Palliag NF 1II (k) 883036 Degussa Dental Product Description: v Sterngold 66 is a White Crown and Bridge Alloy. Indications for Use: Precious alloy for u…
Degussa Dental, Inc.1988—

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 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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
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 Crown and Bridge Dental Restorations.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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
  • K021741Critertion, Model #1067511Sterngold · 2002

Recent decisions in EJS

The EJS category page

  • K041433Bright Gold XHIvoclar Vivadent, Inc. · 2004
  • K040436Simidur SuperiorWieland Dental + Technik GmbH & Co. KG · 2004
  • K022252Sterngold 1, Model 1127781Sterngold · 2002
  • K022469ECO E4Wieland Dental + Technik GmbH & Co. KG · 2002
  • K020192Simidur S2Wieland Dental + Technik GmbH & Co. KG · 2002

https://510kreport.com/device/K021367 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021367: Sterngold 66, Model #1180230.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021367

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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