510(k) · Cleared
ClearedJensen Gold Foil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jensen Industries, Inc. · EJT Alloy, Gold-Based Noble Metal
Cleared on Aug 29, 2002 as substantially equivalent to K915626 (Ivoclar North America, Inc., 1992) after a 55-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Aug 29, 2002
- Review
- 55 days
- Class
- Class II
- Product code
- EJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915626 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK915626 EZ GoldIvoclar North America, Inc. · 1992
- This deviceK022206 Jensen Gold FoilJensen Industries, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915626 | EZ Gold | Ivoclar North America, Inc. | 1992 | — |
| 0 (this device) | K022206 | Jensen Gold Foil | Jensen Industries, Inc. | 2002 | — |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K915626 | EZ GoldSummary page 1…Jensen Gold Foil Common Name: Direct filling gold foil Classification: Class I1 Product Code: EST Predicate Device(s): EZ Gold - K915626 Williams Gold Foil (pre-amendment device) Device Description: Jensen Gold Foil is pure gold, direct… | 1992 |
| * | — | Williams Gold Foil Named without a submission number |
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.
How does its category compare?
All EJT devicesEJT 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
MAUDE reports naming product code EJT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Jensen Gold Foil is pure gold direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022206: Jensen Gold Foil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022206
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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