510(k) · Cleared

Cleared

Lucius 76

K023196510(k) TraditionalCleared Nov 1, 200237-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

Sb Lucius, Inc. · EJT Alloy, Gold-Based Noble Metal

Cleared on Nov 1, 2002 as substantially equivalent to K893385 (Argen Precious Metals, Inc., 1989) after a 37-day review. Its family tree reaches back 1 generation to 1989.

Decided: Nov 1, 2002
Review: 37 days
Class: Class II
Product code: EJT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K893385 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK893385 Argenco 77 Type II Dental Gold AlloyArgen Precious Metals, Inc. · 1989
This deviceK023196 Lucius 76Sb Lucius, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K893385	Argenco 77 Type II Dental Gold Alloy	Argen Precious Metals, Inc.	1989	—
0 (this device)	K023196	Lucius 76	Sb Lucius, Inc.	2002	—

FIG. 1 — Lineage of K023196, 1989–2002Source: 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.

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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
*	K893385	Argenco 77 Type II Dental Gold Alloy Summary page 1 …clinical use Product code: EJT Classification: Class I I Legally marketed device: Argen's ARGENCO 77** 5lO(k) number: 893385 SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS Test methods applied: as in ANWADA 5 and I S 0 9693 Comparison of composition:…	Argen Precious Metals, Inc.	1989	—

Also cleared against K893385: 1 other device →

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.
1 other device also cites its predicate K893385.

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?

This is a yellow casting alloy for inlay / onlays, crowns, short span bridges,

long span bridges, removable partials.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023196 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023196: Lucius 76.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023196

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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