510(k) · Cleared
ClearedEndo Smart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meta Biomed, Inc. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Sep 19, 2014 as substantially equivalent to K111616 (Saeshin Precision Co., Ltd., 2011) and 1 other predicate after a 329-day review. Its family tree reaches back 4 generations to 1997. 6 later devices descend from it.
- Decided
- Sep 19, 2014
- Review
- 329 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K971350 (1997). 7 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 3 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 2 generations backK092412 Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009
- 1 generation backK111616 E-CUBESaeshin Precision Co., Ltd. · 2011
- This deviceK133298 Endo SmartMeta Biomed, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK153285 EMS-200Meta Systems Co., Ltd. · 2016
- Descendant · 2 generations on · 4 of its ownK202906 EndoPilot2Schlumbohm GmbH & Co. KG · 2021
- Descendant · 3 generations on · 1 of its ownK233865 X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK251811 Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK242317 Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K153285EMS-200Meta Systems Co., Ltd. · 2016 · cites it directly5descendants
- K202906EndoPilot2Schlumbohm GmbH & Co. KG · 2021 · 2 generations on4descendants
- K233865X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024 · 3 generations on1descendant
- K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025 · 4 generations on0descendants
- K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −3 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −2 | K092412 | Strong Implant Handpieces | Saeshin Precision Co., Ltd. | 2009 | — |
| −1 | K111616 | E-CUBE | Saeshin Precision Co., Ltd. | 2011 | — |
| 0 (this device) | K133298 | Endo Smart | Meta Biomed, Inc. | 2014 | — |
| +1 | K153285 | EMS-200 | Meta Systems Co., Ltd. | 2016 | — |
| +2 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 | — |
| +3 | K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | 2024 | — |
| +4 | K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | 2025 | — |
| +3 | K242317 | Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111616 | E-CUBESummary page 4…Ltd. Device : E-CUBE 510(k) Number : K111616 Manufacturer: DENTSPLY International Device:… | 2011 |
| Kept off the family tree | K082167 | FDA’s K082167 is Portable X-Ray System, Models Diox-602, Prox Our reading of the summary gave K082167, FDA’s number for Portable X-Ray System, Models Diox-602, Prox (Digimed Corporation). Its FDA name has none of the distinctive words the summary uses for the device it names, “X-Smart Easy”. Kept off the family tree. Summary page 4…ufacturer: DENTSPLY International Device: X-Smart Easy 510(k) number: K082167 4-1 7. Device Description:… | 2008 |
| * | K092614 | X-Smart EasySummary page 7…l Equivalence Endo Smart ES-100 has an intended use similar to the predicate devices, and similar features and technological characteristics as X-Smart Easy (K092614) and E-CUBE (K111616). Additionally, ES-100 used identical Micro Motor, Contra Angle hand piece and files used by E-C… | 2009 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153285 | EMS-200 | 2016 | 5 |
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 17 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K153285 (Meta Systems Co., Ltd., 2016) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K111616.
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. 2014, 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?
Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills
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/K133298 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133298: Endo Smart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133298
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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