510(k) · Cleared

Cleared

V-Supra Plus, Alloy NO. 5025

K993508510(k) TraditionalCleared Dec 6, 199952-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

Metalor Dental USA Corp. · EJT Alloy, Gold-Based Noble Metal

Cleared on Dec 6, 1999 after a 52-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.

Decided: Dec 6, 1999
Review: 52 days
Class: Class II
Product code: EJT
Recalls: None
Predicates: 0

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

This deviceK993508 V-Supra Plus, Alloy NO. 5025Metalor Dental USA Corp. · 1999
Descendant · cites it directly · 0 of its ownK023197 Ceranum 82Sb Lucius, Inc. · 2002
Descendant · cites it directly · 0 of its ownK023200 Ceranum 76Sb Lucius, Inc. · 2002
Descendant · cites it directly · 0 of its ownK021741 Critertion, Model #1067511Sterngold · 2002

Most influential descendants

Showing 3 of 3 · See all

K023197Ceranum 82Sb Lucius, Inc. · 2002 · cites it directly0descendants
K023200Ceranum 76Sb Lucius, Inc. · 2002 · cites it directly0descendants
K021741Critertion, Model #1067511Sterngold · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K993508	V-Supra Plus, Alloy NO. 5025	Metalor Dental USA Corp.	1999	—
+1	K023197	Ceranum 82	Sb Lucius, Inc.	2002	—
+1	K023200	Ceranum 76	Sb Lucius, Inc.	2002	—
+1	K021741	Critertion, Model #1067511	Sterngold	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0

FIG. 1 — Lineage of K993508, 1999–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided
K023197	Ceranum 82	Sb Lucius, Inc.	2002
K023200	Ceranum 76	Sb Lucius, Inc.	2002
K021741	Critertion, Model #1067511	Sterngold	2002

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, K023197 (Sb Lucius, Inc., 2002) has gone furthest, with 0 descendants of its own.

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?

Fabrication of Porcelain-Fused-to-Metal Dental Crowns,

Bridges, and Implant-supported Prosthesis Substructures.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993508 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993508: V-Supra Plus, Alloy NO. 5025.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993508

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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