510(k) · Cleared
ClearedApollo, Model 1124525
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterngold · EJT Alloy, Gold-Based Noble Metal
Cleared on Apr 4, 2002 as substantially equivalent to K905326 (Ivoclar North America, Inc., 1990) and 2 other predicates after a 10-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Apr 4, 2002
- Review
- 10 days
- Class
- Class II
- Product code
- EJT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K895069 (1989). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK895069 Select 40Leach and Dillon Co., Inc. · 1989
- This deviceK020949 Apollo, Model 1124525Sterngold · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895069 | Select 40 | Leach and Dillon Co., Inc. | 1989 | — |
| 0 (this device) | K020949 | Apollo, Model 1124525 | Sterngold | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | K905326 | MinigoldSummary page 1…ng to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class L. Predicate Devices: Alloy Name 510(k) ‘ Manufactured By Minigold (k)905326 Ivoclar North America Suncast (k)923720 Jelenko Select 40 (k)895069 Leach & Dillon Co. Product Description: Apollo is a yellow… | 1990 |
| * | K923720 | SuncastSummary page 1…rug, and Cosmetic Act, the device classification is Class L. Predicate Devices: Alloy Name 510(k) ‘ Manufactured By Minigold (k)905326 Ivoclar North America Suncast (k)923720 Jelenko Select 40 (k)895069 Leach & Dillon Co. Product Description: Apollo is a yellow Crown and Bridge Alloy. Indications for… | 1993 |
| * | K895069 | Select 40Summary page 1…vice classification is Class L. Predicate Devices: Alloy Name 510(k) ‘ Manufactured By Minigold (k)905326 Ivoclar North America Suncast (k)923720 Jelenko Select 40 (k)895069 Leach & Dillon Co. Product Description: Apollo is a yellow Crown and Bridge Alloy. Indications for Use: Precious alloy for use… | 1989 |
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?
- None of the 3 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?
Precious Alloy for use in Crown and Bridge Dental Restorations.
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/K020949 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020949: Apollo, Model 1124525.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020949
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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