510(k) · Cleared
ClearedEndomax Cordless Endodontic Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentamerica · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Jan 7, 2010 as substantially equivalent to K990682 (Nsk Nakanishi, Inc., 1999) and 1 other predicate after a 114-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Jan 7, 2010
- Review
- 114 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K970339 (1997). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK970339 Tri Auto ZXJ. Morita USA, Inc. · 1997
- This deviceK092833 Endomax Cordless Endodontic HandpieceDentamerica · 2010
- Descendant · cites it directly · 3 of its ownK123582 Endo a ClassSaeyang Microtech Co., Ltd. · 2013
- Descendant · 2 generations on · 1 of its ownK143411 Traus EndoSaeshin Precision Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK232810 Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK212043 Traus EndoSaeshin Precision Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K123582Endo a ClassSaeyang Microtech Co., Ltd. · 2013 · cites it directly3descendants
- K143411Traus EndoSaeshin Precision Co., Ltd. · 2015 · 2 generations on1descendant
- K232810Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023 · 2 generations on0descendants
- K212043Traus EndoSaeshin Precision Co., Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970339 | Tri Auto ZX | J. Morita USA, Inc. | 1997 | — |
| 0 (this device) | K092833 | Endomax Cordless Endodontic Handpiece | Dentamerica | 2010 | — |
| +1 | K123582 | Endo a Class | Saeyang Microtech Co., Ltd. | 2013 | — |
| +2 | K143411 | Traus Endo | Saeshin Precision Co., Ltd. | 2015 | — |
| +2 | K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | 2023 | — |
| +3 | K212043 | Traus Endo | Saeshin Precision Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K990682 | Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.)Summary page 1…tory performance standards or special controls exist for this device. Substantially Equivalent Legally Marketed Devices (predicates): ENDO-MATE TC Cordless Handpiece - K990682 Tri Auto ZX Cordless Endodontic Handpiece - K970339… | 1999 |
| * | K970339 | Tri Auto ZXSummary page 1…for this device. Substantially Equivalent Legally Marketed Devices (predicates): ENDO-MATE TC Cordless Handpiece - K990682 Tri Auto ZX Cordless Endodontic Handpiece - K970339 U- ~ ~ ~ - Indica… | 1997 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123582 | Endo a Class | 2013 | 3 |
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?
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. 2010, 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?
The EndomaX is a cordless handpiece used primarily for root canal enlargement. This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092833: Endomax Cordless Endodontic Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092833
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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