510(k) · Cleared
ClearedFlare,File, Fill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lone Star Technologies · EJB Handle, Instrument, Dental
Cleared on Jun 5, 1998 after a 62-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 5, 1998
- Review
- 62 days
- Class
- Class I
- Product code
- EJB
- 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 EJB? 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 EJB devicesEJB Handle, Instrument, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJB
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · EJB
Too few EJB 510(k)s in any year since 2007 to give a median.
Recalls per year · EJB
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EJB
1in 2021
MAUDE reports naming product code EJB, 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 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For use in the preparation of root canals prior to the final filling of the root canals in adult or deciduous teeth. The Dentist or Endodontist examines the patient to determine if the method of treatment is to be the removal of the root canal for the appropriate reasons. After opening the tooth with the access bur the first part of the root canal is exposed to the point where the canals tend to branch out about one third of the way. The Dentist then follows his standard procedure of locating the Apex and removal of the nerve and decayed matter from the canal using the Flare--File--Fill procedures.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981234 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981234: Flare,File, Fill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981234
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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