510(k) · Cleared

Cleared

Appollo 3 Alloy

K032320510(k) TraditionalCleared Oct 1, 200365-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

Dentsply International · EJT Alloy, Gold-Based Noble Metal

Cleared on Oct 1, 2003 as substantially equivalent to K951779 (Degussa Corp., 1995) after a 65-day review. Its family tree reaches back 1 generation to 1995.

Decided: Oct 1, 2003
Review: 65 days
Class: Class II
Product code: EJT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K951779 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK951779 Degulor MDegussa Corp. · 1995
This deviceK032320 Appollo 3 AlloyDentsply International · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951779	Degulor M	Degussa Corp.	1995	—
0 (this device)	K032320	Appollo 3 Alloy	Dentsply International	2003	—

FIG. 1 — Lineage of K032320, 1995–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K951779	Degulor M Summary page 1 …APOLLO 3 ALLOY CLASS I I;IC AT1ON NAME : Gold-based alloy for clinical use (872.3060) PREDICATE DEVICES: Degulor M Alloy K95 1779 DEVICE DESCRIPTION: APOLLO 3 ALLOY is a yellow, high noble. gold-based dental allo\,. INTENDED 1JSE: APOLLO 3 ALLOY is indic…	Degussa Corp.	1995	—

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?

Its one ancestor has no 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

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

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	1
2012	—	0
2013	—	0
2014	—	1
2015	—	0
2016	—	1
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

Fabricating inlays, crowns and small span bridges.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032320 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032320: Appollo 3 Alloy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032320

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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