510(k) Report

510(k) · Cleared

Cleared

GDC-3338, Dental Solder Alloy

K920887510(k) TraditionalCleared Mar 19, 199277-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 Mar 19, 1992 after a 77-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Mar 19, 1992
Review
77 days
Class
Class II
Product code
EJS
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2002: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK920887 GDC-3338, Dental Solder AlloyDeringer-Ney, Inc. · 1992
  2. Descendant · cites it directly · 2 of its ownK983453 Procera Allceram Fusing MaterialNobel Biocare Uas, Inc. · 1998
  3. Descendant · 2 generations on · 0 of its ownK253191 DCMhotbond zirconDental Creativ Management GmbH · 2026
  4. Descendant · 2 generations on · 0 of its ownK020269 Procera Allceram Bridge MaterialProcera Sandvik AB · 2002

Most influential descendants

Showing 3 of 3 · See all
  • K983453Procera Allceram Fusing MaterialNobel Biocare Uas, Inc. · 1998 · cites it directly2descendants
  • K253191DCMhotbond zirconDental Creativ Management GmbH · 2026 · 2 generations on0descendants
  • K020269Procera Allceram Bridge MaterialProcera Sandvik AB · 2002 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920887GDC-3338, Dental Solder AlloyDeringer-Ney, Inc.1992—
+1K983453Procera Allceram Fusing MaterialNobel Biocare Uas, Inc.1998—
+2K253191DCMhotbond zirconDental Creativ Management GmbH2026—
+2K020269Procera Allceram Bridge MaterialProcera Sandvik AB2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200210
202610
FIG. 1 — Lineage of K920887, 1992–2026Source: 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), 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?

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

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K983453Procera Allceram Fusing MaterialNobel Biocare Uas, Inc.19982

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, K983453 (Nobel Biocare Uas, Inc., 1998) has gone furthest, with 2 descendants of its own.

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
  • K925273GDC 3445Deringer-Ney, Inc. · 1992
  • K920922GDC 3367Deringer-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/K920887 · printed Nov 5, 2026

Cite this page

510(k) Report. “K920887: GDC-3338, Dental Solder Alloy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K920887

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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