510(k) · Cleared
ClearedGold Core Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentron Laboratory Technologies · EJH Alloy, Metal, Base
Cleared on Jan 13, 2003 as substantially equivalent to K003039 (Jeneric/Pentron, Inc., 2000) after an 87-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jan 13, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- EJH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003039 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK003039 Gold Core IIJeneric/Pentron, Inc. · 2000
- This deviceK023499 Gold Core PlusPentron Laboratory Technologies · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003039 | Gold Core II | Jeneric/Pentron, Inc. | 2000 | — |
| 0 (this device) | K023499 | Gold Core Plus | Pentron Laboratory Technologies | 2003 | — |
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 EJH? 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 |
|---|---|---|---|
| * | K003039 | Gold Core IISummary page 1…s crowns, bridges, substrate for accepting high expansion porcelains. Gold Core Plus is substantially equivalent to Pentron Laboratory Technologies, LLC., Jewel Cast 11, K003039. Gold Core Plus contains the same elements as Jewel Cast I1 with the exception of one element. However, the addition of this elem… | 2000 |
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 EJH devicesEJH Alloy, Metal, Base: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJH
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · EJH
Too few EJH 510(k)s in any year since 2007 to give a median.
Recalls per year · EJH
No recall names EJH since 2007.
Adverse event reports per year · EJH
1in 2018
MAUDE reports naming product code EJH, 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 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 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 Plus is indicated for use as crowns, bridges, substrate for accepting high expansion porcelains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023499: Gold Core Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023499
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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