510(k) · Cleared
ClearedX-Smart Pro; X-Smart Pro+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona, Inc. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Jul 24, 2024 as substantially equivalent to K202906 (Schlumbohm GmbH & Co. KG, 2021) and 1 other predicate after a 231-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Jul 24, 2024
- Review
- 231 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K971350 (1997). 20 ancestors in all, the oldest K942139 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 6 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 5 generations backK092412 Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009
- 4 generations backK111616 E-CUBESaeshin Precision Co., Ltd. · 2011
- 3 generations backK133298 Endo SmartMeta Biomed, Inc. · 2014
- 2 generations backK153285 EMS-200Meta Systems Co., Ltd. · 2016
- 1 generation backK202906 EndoPilot2Schlumbohm GmbH & Co. KG · 2021
- This deviceK233865 X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK251811 Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −6 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −5 | K092412 | Strong Implant Handpieces | Saeshin Precision Co., Ltd. | 2009 | — |
| −4 | K111616 | E-CUBE | Saeshin Precision Co., Ltd. | 2011 | — |
| −3 | K133298 | Endo Smart | Meta Biomed, Inc. | 2014 | — |
| −2 | K153285 | EMS-200 | Meta Systems Co., Ltd. | 2016 | — |
| −1 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 | — |
| 0 (this device) | K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | 2024 | — |
| +1 | K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K202906 | EndoPilot2Summary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code IK202906 I EndoPilot2 ELC, EKX, E I K15… | 2021 |
| * | K151045 | TENEO Dental Treatment Unit and AccessoriesSummary page 5…Product Code IK202906 I EndoPilot2 ELC, EKX, E I K151045 I Teneo Dental treatment unit and accessories I EIA I K150750… | 2015 |
| † | K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | 2015 |
| † | K111078 | Aeu-26L Elctronic Endodontic System | 2011 |
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 |
|---|---|---|---|
| K251811 | Motor and Apex Module (MaAM) | 2025 | 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?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K251811 (Dentsply Sirona, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K202906.
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. 2024, 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 Endo Tabletop consists of a motorized endodontic handpiece for root canal cleaning and preparation. In addition, some models may also incorporate an electronic apex locator that assists the operator to locate the file tip in the root canal. The Endo Tabletop is intended solely for use by trained dental professionals on patients that need root canal treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233865: X-Smart Pro; X-Smart Pro+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233865
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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