510(k) · Cleared
ClearedMotor and Apex Module (MaAM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona, Inc. · EBW Controller, Foot, Handpiece And Cord
Cleared on Aug 25, 2025 as substantially equivalent to K163131 (Nakanishi, Inc., 2017) and 3 other predicates after a 74-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Aug 25, 2025
- Review
- 74 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K971350 (1997). 25 ancestors in all, the oldest K942139 (1995). No later device cites it as a predicate yet.
- Root · 8 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 7 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 6 generations backK092412 Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009
- 5 generations backK111616 E-CUBESaeshin Precision Co., Ltd. · 2011
- 4 generations backK133298 Endo SmartMeta Biomed, Inc. · 2014
- 3 generations backK153285 EMS-200Meta Systems Co., Ltd. · 2016
- 2 generations backK202906 EndoPilot2Schlumbohm GmbH & Co. KG · 2021
- 1 generation backK233865 X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024
- This deviceK251811 Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −7 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −6 | K092412 | Strong Implant Handpieces | Saeshin Precision Co., Ltd. | 2009 | — |
| −5 | K111616 | E-CUBE | Saeshin Precision Co., Ltd. | 2011 | — |
| −4 | K133298 | Endo Smart | Meta Biomed, Inc. | 2014 | — |
| −3 | K153285 | EMS-200 | Meta Systems Co., Ltd. | 2016 | — |
| −2 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 | — |
| −1 | K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | 2024 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 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? (4)
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 |
|---|---|---|---|
| * | K163131 | A-dec NLZ Electric Motor SystemSummary page 5…4200 Product Code(s) EBW, LQY | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K163131 A-dec NLZ Electric Motor System EBW K150909 Motor BL ISO E (a physical part of Intego) EIA K151045 Motor BL Implant (a physical p… | 2017 |
| * | K150909 | INTEGO Family and AccesoriesSummary page 5…keted Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K163131 A-dec NLZ Electric Motor System EBW K150909 Motor BL ISO E (a physical part of Intego) EIA K151045 Motor BL Implant (a physical part of Teneo) EIA K233865 X-Smart Pro; X-Sma… | 2015 |
| * | K151045 | TENEO Dental Treatment Unit and AccessoriesSummary page 5…Predicate Trade Name (Primary Predicate is listed first) Product Code K163131 A-dec NLZ Electric Motor System EBW K150909 Motor BL ISO E (a physical part of Intego) EIA K151045 Motor BL Implant (a physical part of Teneo) EIA K233865 X-Smart Pro; X-Smart Pro+ EKX Device Description Summary 21 CFR 807.92(a)… | 2015 |
| * | K233865 | X-Smart Pro; X-Smart Pro+Summary page 5…) Product Code K163131 A-dec NLZ Electric Motor System EBW K150909 Motor BL ISO E (a physical part of Intego) EIA K151045 Motor BL Implant (a physical part of Teneo) EIA K233865 X-Smart Pro; X-Smart Pro+ EKX Device Description Summary 21 CFR 807.92(a)(4) This device is a system that includes a control mod… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- None of the 25 ancestors has a recall.
- 3 other devices also cite its predicate K163131.
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. 2025, 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 Midwest Motor Control Module includes a control unit, ports for three motors, an apex location port, and a peristaltic pump port. The motor ports are compatible with the Midwest Power Lux and Midwest Power Lux Implant. The Midwest Power Lux electric micromotor is intended for use as a drive for rotating and oscillating straight and contra-angle hand pieces for endodontic and general dental purposes. The Midwest Power Lux Implant motor is intended for…
Read the full statement (144 words)
The Midwest Motor Control Module includes a control unit, ports for three motors, an apex location port, and a peristaltic pump port. The motor ports are compatible with the Midwest Power Lux and Midwest Power Lux Implant.
The Midwest Power Lux electric micromotor is intended for use as a drive for rotating and oscillating straight and contra-angle hand pieces for endodontic and general dental purposes.
The Midwest Power Lux Implant motor is intended for use in implant placement and includes a closed system for delivery of sterile solution via peristaltic pump operation.
The apex locator supports the dentist in the determination of the working length during the endodontic treatment.
These motors are to be driven by the control unit. The control unit is an internal component of a dental delivery system.
The use of this product is intended exclusively for duly qualified dental practitioners.
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/K251811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251811: Motor and Apex Module (MaAM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251811
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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