510(k) · Cleared
ClearedTF Rotary Nickel Titanium File
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ormco Corp. · EKS File, Pulp Canal, Endodontic
Cleared on Dec 13, 2006 after a 79-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Dec 13, 2006
- Review
- 79 days
- Class
- Class I
- Product code
- EKS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK062856 TF Rotary Nickel Titanium FileOrmco Corp. · 2006
- Descendant · cites it directly · 0 of its ownK082325 Apexum AblatorApexum, Ltd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K082325Apexum AblatorApexum, Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062856 | TF Rotary Nickel Titanium File | Ormco Corp. | 2006 | — |
| +1 | K082325 | Apexum Ablator | Apexum, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 EKS? 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? (1)
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 |
|---|---|---|---|
| * | — | Sybron Endo, Quantec Series 2000 Endodontic File Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082325 | Apexum Ablator | 2009 | 0 |
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, K082325 (Apexum, Ltd., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EKS devicesEKS File, Pulp Canal, Endodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EKS
FDA has decided no EKS device since 2007.
Median 510(k) review, days · EKS
Too few EKS 510(k)s in any year since 2007 to give a median.
Recalls per year · EKS
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EKS
324in 2025
MAUDE reports naming product code EKS, 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 | 104 |
| 2008 | 0 | — | 1 | 10 |
| 2009 | 0 | — | 0 | 16 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 20 |
| 2012 | 0 | — | 1 | 14 |
| 2013 | 0 | — | 0 | 30 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 0 | — | 0 | 56 |
| 2016 | 0 | — | 0 | 28 |
| 2017 | 0 | — | 0 | 53 |
| 2018 | 0 | — | 0 | 258 |
| 2019 | 0 | — | 0 | 468 |
| 2020 | 0 | — | 0 | 421 |
| 2021 | 0 | — | 0 | 342 |
| 2022 | 0 | — | 0 | 291 |
| 2023 | 0 | — | 0 | 264 |
| 2024 | 0 | — | 0 | 313 |
| 2025 | 0 | — | 0 | 324 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TF Rotary Nickel Titanium File is a rotary endodontic file designed for use in root canal preparation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062856 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062856: TF Rotary Nickel Titanium File.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062856
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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