510(k) · Cleared
ClearedGold Core 35
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentron Laboratory Technologies · EJT Alloy, Gold-Based Noble Metal
Cleared on Dec 18, 2002 as substantially equivalent to K993173 (Jeneric/Pentron, Inc., 1999) after a 61-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Dec 18, 2002
- Review
- 61 days
- Class
- Class II
- Product code
- EJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922958 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 | Decided |
|---|---|---|---|
| * | K993173 | Gold Core 55Summary page 1…owns, bridges, implant superstructures and substrates for low fusing, high expansion porcelains and composites. Gold Core 35 is substantially equivalent to Gold Core 55, K993 173 with the exception of a minor few elements. However, the addition of these elements does not affecl. safety and effectiveness.… | 1999 |
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- None of the 2 ancestors has a 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?
Gold Core 35 is a noble, yellow alloy to be used for inlays, onlays, single crown, bridges, implant superstructures and substrate for low fusing, high expansion porcelains and composites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023501 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023501: Gold Core 35.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023501
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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