510(k) · Cleared
ClearedE3 Torque Control Motor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International, Inc. · EBW Controller, Foot, Handpiece And Cord
Cleared on May 26, 2011 as substantially equivalent to K092614 (Dentsply Interntional, 2009) after a 164-day review. Its family tree reaches back 2 generations to 1999. 8 later devices descend from it.
- Decided
- May 26, 2011
- Review
- 164 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K990682 (1999). 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK990682 Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max)…Nsk Nakanishi, Inc. · 1999
- 1 generation backK092614 X-Smart EasyDentsply Interntional · 2009
- This deviceK103653 E3 Torque Control MotorDentsply International, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK161213 XSmart iQDentsply Sirona · 2017
- Descendant · cites it directly · 2 of its ownK150750 Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH · 2015
- Descendant · 2 generations on · 1 of its ownK163402 NLZ Motor SystemNakanishi, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK111623 I-Endo DualSatelec - Acteon Group · 2012
- Descendant · 3 generations on · 0 of its ownK251701 Star E900 Electric SystemDentalez, Inc., Stardental Division · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K161213XSmart iQDentsply Sirona · 2017 · cites it directly2descendants
- K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH · 2015 · cites it directly2descendants
- K163402NLZ Motor SystemNakanishi, Inc. · 2017 · 2 generations on1descendant
- K111623I-Endo DualSatelec - Acteon Group · 2012 · cites it directly1descendant
- K251701Star E900 Electric SystemDentalez, Inc., Stardental Division · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990682 | Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate… | Nsk Nakanishi, Inc. | 1999 | — |
| −1 | K092614 | X-Smart Easy | Dentsply Interntional | 2009 | — |
| 0 (this device) | K103653 | E3 Torque Control Motor | Dentsply International, Inc. | 2011 | — |
| +1 | K161213 | XSmart iQ | Dentsply Sirona | 2017 | — |
| +1 | K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | 2015 | — |
| +2 | K163402 | NLZ Motor System | Nakanishi, Inc. | 2017 | — |
| +1 | K111623 | I-Endo Dual | Satelec - Acteon Group | 2012 | — |
| +3 | K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2024 | 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 EBW? 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 EBW device
- #1 K251701 Star E900 Electric Systemscore 12.2 · 6 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 |
|---|---|---|---|
| * | K092614 | X-Smart EasySummary page 1…: 872.4200 * Device Class: I * Product Code: EKX 3. Predicate Device: X-SmartTM Easy, K092614 4. Description of Device: The e3 Torque Control Motor is an electric motor-driven handpiece intended for… | 2009 |
What descends from it? (8)
3 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K161213 (Dentsply Sirona, 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K092614.
How does its category compare?
All EBW devicesEBW Controller, Foot, Handpiece And Cord: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · EBW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBW
220in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBW
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBW
13in 2025
MAUDE reports naming product code EBW, 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 | — | 0 | 0 |
| 2009 | 5 | 112 | 0 | 16 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 3 | 226 | 0 | 1 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 3 | 189 | 0 | 4 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 4 | 227 | 0 | 13 |
| 2018 | 1 | — | 0 | 46 |
| 2019 | 2 | — | 0 | 55 |
| 2020 | 1 | — | 0 | 71 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 6 | 479 | 0 | 31 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 4 | 268 | 0 | 14 |
| 2025 | 3 | 220 | 0 | 13 |
| 2026 | 3 | 269 | 0 | — |
What is it indicated for?
The e3 Torque Control Motor is a medical device designed for use by dentists for use with dental root canal instruments in continuous rotation with torque control or in reciprocating movement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103653 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103653: E3 Torque Control Motor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103653
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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