510(k) · Cleared
ClearedElec-Mate E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nakanishi, Inc. · EBW Controller, Foot, Handpiece And Cord
Cleared on Sep 11, 2001 after an 83-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Sep 11, 2001
- Review
- 83 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK011926 Elec-Mate ENakanishi, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK083252 Nutorque Programmable Electric SystemDentalez Group, Stardental Division · 2009
- Descendant · 2 generations on · 2 of its ownK090937 E-Statis 40 SystemScican, Ltd. · 2009
- Descendant · 3 generations on · 1 of its ownK163402 NLZ Motor SystemNakanishi, Inc. · 2017
- Descendant · 4 generations on · 0 of its ownK251701 Star E900 Electric SystemDentalez, Inc., Stardental Division · 2026
Most influential descendants
Showing 4 of 4 · See all- K083252Nutorque Programmable Electric SystemDentalez Group, Stardental Division · 2009 · cites it directly3descendants
- K090937E-Statis 40 SystemScican, Ltd. · 2009 · 2 generations on2descendants
- K163402NLZ Motor SystemNakanishi, Inc. · 2017 · 3 generations on1descendant
- K251701Star E900 Electric SystemDentalez, Inc., Stardental Division · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011926 | Elec-Mate E | Nakanishi, Inc. | 2001 | — |
| +1 | K083252 | Nutorque Programmable Electric System | Dentalez Group, Stardental Division | 2009 | — |
| +2 | K090937 | E-Statis 40 System | Scican, Ltd. | 2009 | — |
| +3 | K163402 | NLZ Motor System | Nakanishi, Inc. | 2017 | — |
| +4 | K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2017 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083252 | Nutorque Programmable Electric System | 2009 | 3 |
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?
- Of its descendants, K083252 (Dentalez Group, Stardental Division, 2009) has gone furthest, with 3 descendants of its own.
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.
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 device is a control unit, which is connected to an ac power supply and a handpiece hose, that drives a dc electric micromotor, and turns on or off or regulates the speed of the motor by the foot control of the dental unit. It has a provision for a low voltage dc power supply for the handpiece with light. It is intended as a control unit for the handpiece used in general dental applications for work such as cutting a tooth for crown preparation…
Read the full statement (164 words)
The device is a control unit, which is connected to an ac power supply and a handpiece hose, that drives a dc electric micromotor, and turns on or off or regulates the speed of the motor by the foot control of the dental unit. It has a provision for a low voltage dc power supply for the handpiece with light. It is intended as a control unit for the handpiece used in general dental applications for work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, prophylaxis and endodontic treatment, with use of straight, right- and contra-angle ISO E-type attachment, with or without internal coolant, of equal, step-up, or step-down speed sheath. The maximum free speed of the electric micromotor is 40,000 rpm.
Special Note:
The electric micromotor and its cord are not autoclavable; therefore, an adequate covering by plastic sleeving as commonly used in dental for infection control method should be used during treatment.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011926 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011926: Elec-Mate E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011926
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026