510(k) · Cleared
ClearedSmartburs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.S. White Burs, Inc. · EJL Bur, Dental
Cleared on Jun 20, 2008 after a 101-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 20, 2008
- Review
- 101 days
- Class
- Class I
- Product code
- EJL
- 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 EJL? 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 EJL devicesEJL Bur, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EJL
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · EJL
Too few EJL 510(k)s in any year since 2007 to give a median.
Recalls per year · EJL
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EJL
54in 2025
MAUDE reports naming product code EJL, 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 | 1 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 32 |
| 2009 | 0 | — | 1 | 53 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 15 |
| 2019 | 0 | — | 1 | 17 |
| 2020 | 0 | — | 5 | 7 |
| 2021 | 0 | — | 0 | 21 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 1 | 25 |
| 2025 | 0 | — | 0 | 54 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
After primary access using another instrument, Smartburs is intended to selectively
remove decayed dentin, without removal of healthy dentin from tooth surfaces.
Smartburs is not designed to cut or remove enamel, composite, amalgam, cementum,
or healthy dentin.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K080687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080687: Smartburs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080687
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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