510(k) · Cleared
ClearedSilverfil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dunia Perwira Manufacturing Sdn. Bhd. · EJJ Alloy, Amalgam
Cleared on Nov 15, 2005 after an 8-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 15, 2005
- Review
- 8 days
- Class
- Class II
- Product code
- EJJ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EJJ? 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’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All EJJ devicesEJJ Alloy, Amalgam: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJJ
FDA has decided no EJJ device since 2007.
Median 510(k) review, days · EJJ
Too few EJJ 510(k)s in any year since 2007 to give a median.
Recalls per year · EJJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EJJ
2in 2021
MAUDE reports naming product code EJJ, 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 | 49 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 22 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Silvertul amalgam is used by dental professionals to fill tooth cavities It is used in the same way as other amalgams used in the world today Its usage and handling techniques are the same as other amalgams
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K053114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053114: Silverfil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053114
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026