510(k) · Cleared
ClearedE-CUBE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saeshin Precision Co., Ltd. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Aug 19, 2011 as substantially equivalent to K092614 (Dentsply Interntional, 2009) and 1 other predicate after a 70-day review. Its family tree reaches back 3 generations to 1997. 10 later devices descend from it.
- Decided
- Aug 19, 2011
- Review
- 70 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971350 (1997). 6 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 2 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 1 generation backK092412 Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009
- This deviceK111616 E-CUBESaeshin Precision Co., Ltd. · 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
- Descendant · 4 generations on · 1 of its ownK233865 X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK143411 Traus EndoSaeshin Precision Co., Ltd. · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K233865X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024 · 4 generations on1descendant
- K143411Traus EndoSaeshin Precision Co., Ltd. · 2015 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −2 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −1 | K092412 | Strong Implant Handpieces | Saeshin Precision Co., Ltd. | 2009 | — |
| 0 (this device) | K111616 | E-CUBE | Saeshin Precision Co., Ltd. | 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 | — |
| +4 | K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | 2024 | — |
| +1 | K143411 | Traus Endo | Saeshin Precision Co., Ltd. | 2015 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 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? (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 |
|---|---|---|---|
| * | K092614 | X-Smart EasySummary page 1…ame - B-CUBE Common Name - Dental handpiece and accessories Classification Name - Handpiece, Direct drive, AC-powered 3. Predicate Device: X-Smart Easy, K092614 STRONG Implant Handpiece, K092412 4. Classifications Names & Citations: EKX, 872.4200 5. Description: The B-CUB… | 2009 |
| * | K092412 | Strong Implant HandpiecesSummary page 1…andpiece and accessories Classification Name - Handpiece, Direct drive, AC-powered 3. Predicate Device: X-Smart Easy, K092614 STRONG Implant Handpiece, K092412 4. Classifications Names & Citations: EKX, 872.4200 5. Description: The B-CUBE is an AC-powered device that includes… | 2009 |
What descends from it? (10)
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 14 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K133298 (Meta Biomed, Inc., 2014) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K092614.
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. 2011, 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 B-CUBE is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills(Gates-Glidden).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111616: E-CUBE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111616
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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