510(k) · Cleared
ClearedBio Herador SG, Bio Header GG, Herador S, Bio Herador N, Herabond, Heraloy G, Albabond, Bio Maingold SG, Maingold SG, HE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jelenko Co. · EJT Alloy, Gold-Based Noble Metal
Cleared on Jan 10, 2001 after a 50-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jan 10, 2001
- Review
- 50 days
- Class
- Class II
- Product code
- EJT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK003603 Bio Herador SG, Bio Header GG, Herador S, Bio Herador N, Herabond…Jelenko Co. · 2001
- Descendant · cites it directly · 0 of its ownK033446 APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82We Dong Myung Dental Industrial Co., Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK033435 E-Sarang 86, DM78, DM55We Dong Myung Dental Industrial Co., Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK030206 APEX 90We Dong Myung Dental Industrial Co., Ltd. · 2003
Most influential descendants
Showing 3 of 3 · See all- K033446APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82We Dong Myung Dental Industrial Co., Ltd. · 2003 · cites it directly0descendants
- K033435E-Sarang 86, DM78, DM55We Dong Myung Dental Industrial Co., Ltd. · 2003 · cites it directly0descendants
- K030206APEX 90We Dong Myung Dental Industrial Co., Ltd. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003603 | Bio Herador SG, Bio Header GG, Herador S, Bio Herador N, Herabond, Heraloy G… | Jelenko Co. | 2001 | — |
| +1 | K033446 | APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82 | We Dong Myung Dental Industrial Co., Ltd. | 2003 | — |
| +1 | K033435 | E-Sarang 86, DM78, DM55 | We Dong Myung Dental Industrial Co., Ltd. | 2003 | — |
| +1 | K030206 | APEX 90 | We Dong Myung Dental Industrial Co., Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K033446 (We Dong Myung Dental Industrial Co., Ltd., 2003) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K003603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003603: Bio Herador SG, Bio Header GG, Herador S, Bio Herador N, Herabond, Heraloy G, Albabond, Bio Maingold SG, Maingold SG, HE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003603
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026