510(k) · Cleared

Cleared

Gold Core 55

K993173510(k) TraditionalCleared Oct 26, 199934-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

Jeneric/Pentron, Inc. · EJT Alloy, Gold-Based Noble Metal

Cleared on Oct 26, 1999 as substantially equivalent to K922958 (Jeneric/Pentron, Inc., 1993) after a 34-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Oct 26, 1999
Review: 34 days
Class: Class II
Product code: EJT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K922958 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK922958 KB58-KFJeneric/Pentron, Inc. · 1993
This deviceK993173 Gold Core 55Jeneric/Pentron, Inc. · 1999
Descendant · cites it directly · 0 of its ownK023501 Gold Core 35Pentron Laboratory Technologies · 2002

Most influential descendants

Showing 1 of 1 · See all

K023501Gold Core 35Pentron Laboratory Technologies · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922958	KB58-KF	Jeneric/Pentron, Inc.	1993	—
0 (this device)	K993173	Gold Core 55	Jeneric/Pentron, Inc.	1999	—
+1	K023501	Gold Core 35	Pentron Laboratory Technologies	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K993173, 1993–2002Source: 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
*	K922958	KB58-KF Summary page 1 …tive composites. Particularly to be used with OPC Low Wear, K982377, which is a low wear porcelain. We belicve that Gold Core 55 is substantially cquivalent, to KB58-KF, K922958, Jeneric/Pentron, Inc., which is currently in commercial distribution in the U.S. A. The chemical composition of Gold Core 55 is…	Jeneric/Pentron, Inc.	1993	—
†	K982377	Opc Lowwear Porcelain	Jeneric/Pentron, Inc.	1998	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K023501	Gold Core 35	Pentron Laboratory Technologies	2002	0

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.
Of its descendants, K023501 (Pentron Laboratory Technologies, 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?

Gold Core 55 is a Type IV, high noble, yellow alloy to be used for inlays, onlays, single crown briges, implant superstructures and substrate for low wear products and other medium expansion lower fusing porcelains and indirect restorative composites. Particularly, OPC Low Wecar, K982377, Jeneric/Pencron, which 1s a low temperature ceramic.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993173 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993173: Gold Core 55.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993173

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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