510(k) · Cleared

Cleared

Helioform Gold-Based Alloy

K990670510(k) TraditionalCleared Apr 2, 199931-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

C. Hafner GmbH & Co. · EJT Alloy, Gold-Based Noble Metal

Cleared on Apr 2, 1999 as substantially equivalent to K980613 (Micro Dental Laboratories, 1998) after a 31-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: Apr 2, 1999
Review: 31 days
Class: Class II
Product code: EJT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K980613 (1998). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK980613 Progold Electrocoping SystemMicro Dental Laboratories · 1998
This deviceK990670 Helioform Gold-Based AlloyC. Hafner GmbH & Co. · 1999
Descendant · cites it directly · 0 of its ownK032267 R&D Designation AP-052-5Jensen Industries, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all

K032267R&D Designation AP-052-5Jensen Industries, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K990670, 1998–2003Source: 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
*	K980613	Progold Electrocoping System Summary page 1 …F-Goldkonzentrat HF-Elektrolyt Electrolytic gold Classification name: gold based alloy Legally marketed equivalent device: Progold Electrocoping System 510 (k) number: K 980613 The Helioform System is used to fabricate i. e. inlays, onlays and crowns by a electroforming process. Electroformed gold frame-…	Micro Dental Laboratories	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
K032267	R&D Designation AP-052-5	Jensen Industries, Inc.	2003	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, K032267 (Jensen Industries, Inc., 2003) 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?

Indicated for fixed and removable dental tooth replacement as follows:

Crowns

Inlays, Onlays, Overlays, Partial Crowns

Telescopes, Cones, Overdentures

Direct Technique

Double Crown Systems

Implant Suprastructures

Bridge Structures

Baseplates

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/K990670 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990670: Helioform Gold-Based Alloy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990670

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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