510(k) · Cleared
ClearedXSmart iQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · EBW Controller, Foot, Handpiece And Cord
Cleared on Feb 10, 2017 as substantially equivalent to K103653 (Dentsply International, Inc., 2011) after a 287-day review. Its family tree reaches back 3 generations to 1999. 2 later devices descend from it.
- Decided
- Feb 10, 2017
- Review
- 287 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K990682 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK990682 Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max)…Nsk Nakanishi, Inc. · 1999
- 2 generations backK092614 X-Smart EasyDentsply Interntional · 2009
- 1 generation backK103653 E3 Torque Control MotorDentsply International, Inc. · 2011
- This deviceK161213 XSmart iQDentsply Sirona · 2017
- Descendant · cites it directly · 0 of its ownK233288 NLZ Built-In Motor SystemNakanishi, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK233117 Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)Nakanishi, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990682 | Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate… | Nsk Nakanishi, Inc. | 1999 | — |
| −2 | K092614 | X-Smart Easy | Dentsply Interntional | 2009 | — |
| −1 | K103653 | E3 Torque Control Motor | Dentsply International, Inc. | 2011 | — |
| 0 (this device) | K161213 | XSmart iQ | Dentsply Sirona | 2017 | — |
| +1 | K233288 | NLZ Built-In Motor System | Nakanishi, Inc. | 2024 | — |
| +1 | K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Nakanishi, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K103653 | E3 Torque Control MotorSummary page 4…• Product Code: EBW Predicate Device: Predicate Device Name 510(k) Company Name e3 Torque Control Motor K103653 Dentsply Sirona Description of Device: The XSmart iQ is a cordless motor hand-piece having a power stage (motor hand-pie… | 2011 |
| † | K972436 | T1 Line Dental Handpieces | 1997 |
What descends from it? (2)
2 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 18 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K233288 (Nakanishi, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K103653.
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. 2017, 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?
XSmart iQ is a cordless motor hand-piece with torque control used for driving files in both reciprocating and continuous
mode during an endodontic procedure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161213: XSmart iQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161213
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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