510(k) · Cleared
ClearedApexum Ablator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apexum, Ltd. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Apr 21, 2009 as substantially equivalent to K971603 (Dentsply Intl., 1997) and 3 other predicates after a 250-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Apr 21, 2009
- Review
- 250 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K951607 (1995). 5 ancestors in all, the oldest K920978 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951607 | Sureflex Files | Dentsply Intl. | 1995 | — |
| −1 | K971603 | Sterile Sureflex Files and Instruments | Dentsply Intl. | 1997 | — |
| 0 (this device) | K082325 | Apexum Ablator | Apexum, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 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 EKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EKX device
- #1 K261987 Reusable SmartPegscore 13.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K971603 | Sterile Sureflex Files and InstrumentsSummary page 1…r gear driven, dental, file, pulp canal, endodontic Device Class: Class I Predicate Devices: * K971603 Sterile Sureflex Files and Instruments * K062856 TF Rotary Nickel Titanium File… | 1997 |
| * | K062856 | TF Rotary Nickel Titanium FileSummary page 1…Device Class: Class I Predicate Devices: * K971603 Sterile Sureflex Files and Instruments * K062856 TF Rotary Nickel Titanium File · K004031 NT Swift; TI\TEC; Gates Glidden;… | 2006 |
| * | K004031 | NT Swift; TI\Tec; Gates Glidden Drills; Dental Power Endodontic Hand FilesSummary page 1…* K971603 Sterile Sureflex Files and Instruments * K062856 TF Rotary Nickel Titanium File · K004031 NT Swift; TI\TEC; Gates Glidden; Drills; Dental Power… | 2001 |
| * | K920978 | Ula (Poliglecaprone 251) Synthetic Absor Sut, DyedSummary page 1…· K004031 NT Swift; TI\TEC; Gates Glidden; Drills; Dental Power * K920978 ULA (poliglecaprone 251) synthetic absor CONFIDENTIAL Traditional 510(k) P… | 1994 |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 11.9 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All EKX devicesEKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EKX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EKX
244in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EKX
No recall names EKX since 2007.
Adverse event reports per year · EKX
9in 2025
MAUDE reports naming product code EKX, 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 | 9 |
| 2008 | 3 | 101 | 0 | 10 |
| 2009 | 4 | 186 | 0 | 11 |
| 2010 | 3 | 114 | 0 | 20 |
| 2011 | 4 | 75 | 0 | 6 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 2 | — | 0 | 45 |
| 2014 | 3 | 251 | 0 | 102 |
| 2015 | 3 | 178 | 0 | 68 |
| 2016 | 3 | 274 | 0 | 66 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 3 | 293 | 0 | 49 |
| 2019 | 3 | 349 | 0 | 56 |
| 2020 | 1 | — | 0 | 67 |
| 2021 | 5 | 214 | 0 | 79 |
| 2022 | 3 | 359 | 0 | 37 |
| 2023 | 4 | 152 | 0 | 14 |
| 2024 | 4 | 276 | 0 | 19 |
| 2025 | 5 | 244 | 0 | 9 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Removal of necrotic or inflamed tissue from the apical foramen and periapical region during root canal treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082325: Apexum Ablator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082325
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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