510(k) · Cleared
ClearedX-Smart Easy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Interntional · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Dec 2, 2009 as substantially equivalent to K990682 (Nsk Nakanishi, Inc., 1999) after a 98-day review. Its family tree reaches back 1 generation to 1999. 20 later devices descend from it.
- Decided
- Dec 2, 2009
- Review
- 98 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990682 (1999). 20 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK990682 Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max)…Nsk Nakanishi, Inc. · 1999
- This deviceK092614 X-Smart EasyDentsply Interntional · 2009
- Descendant · cites it directly · 10 of its ownK111616 E-CUBESaeshin Precision Co., Ltd. · 2011
- Descendant · cites it directly · 8 of its ownK103653 E3 Torque Control MotorDentsply International, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK133298 Endo SmartMeta Biomed, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK153285 EMS-200Meta Systems Co., Ltd. · 2016
- Descendant · 3 generations on · 4 of its ownK202906 EndoPilot2Schlumbohm GmbH & Co. KG · 2021
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K111616E-CUBESaeshin Precision Co., Ltd. · 2011 · cites it directly10descendants
- K103653E3 Torque Control MotorDentsply International, Inc. · 2011 · cites it directly8descendants
- K133298Endo SmartMeta Biomed, Inc. · 2014 · cites it directly6descendants
- K153285EMS-200Meta Systems Co., Ltd. · 2016 · 2 generations on5descendants
- K202906EndoPilot2Schlumbohm GmbH & Co. KG · 2021 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990682 | Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate… | Nsk Nakanishi, Inc. | 1999 | — |
| 0 (this device) | K092614 | X-Smart Easy | Dentsply Interntional | 2009 | — |
| +1 | K111616 | E-CUBE | Saeshin Precision Co., Ltd. | 2011 | — |
| +1 | K103653 | E3 Torque Control Motor | Dentsply International, Inc. | 2011 | — |
| +1 | K133298 | Endo Smart | Meta Biomed, Inc. | 2014 | — |
| +2 | K153285 | EMS-200 | Meta Systems Co., Ltd. | 2016 | — |
| +3 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K990682 | Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.)Summary page 1…Device Class: I Product Code: EKX 3. Predicate Device: Prophy-Mate and Endo Mate Motor Handpiece (K990682) 4. Description of Device: The X-Smart Easy is an electric motor-driven handpiece intended for root canal… | 1999 |
What descends from it? (20)
See all 203 later devices cite it directly; ranked here by how many devices descend from each in turn.
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. 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?
X-Srnart Easy is indicated for use by dentists in standard endodontic procedures using rotary endodonftic files and rotary endodontic drills (Gates-Glidden).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092614: X-Smart Easy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092614
Report an extraction error
Are you the manufacturer?
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