510(k) Report

510(k) · Cleared

Cleared

Sterngold 1, Model 1127781

K022252510(k) AbbreviatedCleared Sep 19, 200269-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 Sep 19, 2002 as substantially equivalent to K905330 (Ivoclar North America, Inc., 1990) and 1 other predicate after a 69-day review. Its family tree reaches back 1 generation to 1989.

Decided
Sep 19, 2002
Review
69 days
Class
Class II
Product code
EJS
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K895064 (1989). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1990: 1 other ancestorK895064 · Monogram II · Leach and Dillon Co., Inc. · 19891985199019952000
Other ancestors, by generation 1 generation back: 1 other ancestor K895064 · Monogram II · Leach and Dillon Co., Inc. · 19890
  1. Root · 1 generation backK895064 Monogram IILeach and Dillon Co., Inc. · 1989
  2. This deviceK022252 Sterngold 1, Model 1127781Sterngold · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K895064Monogram IILeach and Dillon Co., Inc.1989—
0 (this device)K022252Sterngold 1, Model 1127781Sterngold2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
FIG. 1 — Lineage of K022252, 1989–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

What was it cleared against? (2)

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
*K905330Harmony Line Alloys
Summary page 1
…is Class Pre lica.te I kvices: Alloy Name 510(k) Manufactured By . I-Iarmony Medium (k) 905330 Ivoclar . Monogram 11 (k) 895064 Leach & Dillon Prc iiuc t DIwripti…
Ivoclar North America, Inc.1990—
*K895064Monogram II
Summary page 1
…510(k) Manufactured By . I-Iarmony Medium (k) 905330 Ivoclar . Monogram 11 (k) 895064 Leach & Dillon Prc iiuc t DIwription: Ste ngcld I is a Yellow Crown and Bridge Alloy. Ind icalioni for Use: Pre…
Leach and Dillon Co., Inc.1989—

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 2 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 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
  • K021741Critertion, Model #1067511Sterngold · 2002
  • K021045Era ImplantSterngold · 2002

Recent decisions in EJS

The EJS category page

  • K041433Bright Gold XHIvoclar Vivadent, Inc. · 2004
  • K040436Simidur SuperiorWieland Dental + Technik GmbH & Co. KG · 2004
  • K022469ECO E4Wieland Dental + Technik GmbH & Co. KG · 2002
  • K021367Sterngold 66, Model #1180230Sterngold · 2002
  • K020192Simidur S2Wieland Dental + Technik GmbH & Co. KG · 2002

https://510kreport.com/device/K022252 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022252: Sterngold 1, Model 1127781.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022252

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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