510(k) Report

510(k) · Cleared

Cleared

GDC 3445

K925273510(k) TraditionalCleared Dec 21, 199263-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

Deringer-Ney, Inc. · EJS Alloy, Other Noble Metal

Cleared on Dec 21, 1992 after a 63-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Dec 21, 1992
Review
63 days
Class
Class II
Product code
EJS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K925273Source: FDA 510(k) database · 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.

Planning a device in EJS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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?

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.

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—

More from Deringer-Ney, Inc.

46 FDA decisions under this applicant name. See the company

  • K933178GDC 3509Deringer-Ney, Inc. · 1993
  • K930481Dental Casting Alloy Modification-PF-4Deringer-Ney, Inc. · 1993
  • K930482Dental Casting Alloy, Modification - PF-3Deringer-Ney, Inc. · 1993
  • K920922GDC 3367Deringer-Ney, Inc. · 1992
  • K920060Dental Solder AlloyDeringer-Ney, Inc. · 1992

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
  • K021367Sterngold 66, Model #1180230Sterngold · 2002

https://510kreport.com/device/K925273 · printed Nov 5, 2026

Cite this page

510(k) Report. “K925273: GDC 3445.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K925273

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