510(k) · Cleared

Cleared

Progold Electrocoping System

K980613510(k) TraditionalCleared Mar 9, 199819-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

Micro Dental Laboratories · EJT Alloy, Gold-Based Noble Metal

Cleared on Mar 9, 1998 after a 19-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Mar 9, 1998
Review: 19 days
Class: Class II
Product code: EJT
Recalls: None
Predicates: 0

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

This deviceK980613 Progold Electrocoping SystemMicro Dental Laboratories · 1998
Descendant · cites it directly · 1 of its ownK990670 Helioform Gold-Based AlloyC. Hafner GmbH & Co. · 1999
Descendant · 2 generations on · 0 of its ownK032267 R&D Designation AP-052-5Jensen Industries, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all

K990670Helioform Gold-Based AlloyC. Hafner GmbH & Co. · 1999 · cites it directly1descendant
K032267R&D Designation AP-052-5Jensen Industries, Inc. · 2003 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K980613	Progold Electrocoping System	Micro Dental Laboratories	1998	—
+1	K990670	Helioform Gold-Based Alloy	C. Hafner GmbH & Co.	1999	—
+2	K032267	R&D Designation AP-052-5	Jensen Industries, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2003	1	0

FIG. 1 — Lineage of K980613, 1998–2003Source: 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

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What was it cleared against?

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

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K990670	Helioform Gold-Based Alloy	C. Hafner GmbH & Co.	1999	1

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, K990670 (C. Hafner GmbH & Co., 1999) has gone furthest, with 1 descendant 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 24 karat 99.96% pure gold substructure for porcelain fused to metal restorations.

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/K980613 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980613: Progold Electrocoping System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980613

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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