510(k) · Cleared
ClearedNutorque Programmable Electric System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalez Group, Stardental Division · EBW Controller, Foot, Handpiece And Cord
Cleared on Feb 18, 2009 as substantially equivalent to K011926 (Nakanishi, Inc., 2001) after a 106-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Feb 18, 2009
- Review
- 106 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011926 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011926 Elec-Mate ENakanishi, Inc. · 2001
- This deviceK083252 Nutorque Programmable Electric SystemDentalez Group, Stardental Division · 2009
- Descendant · cites it directly · 2 of its ownK090937 E-Statis 40 SystemScican, Ltd. · 2009
- Descendant · 2 generations on · 1 of its ownK163402 NLZ Motor SystemNakanishi, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK251701 Star E900 Electric SystemDentalez, Inc., Stardental Division · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011926 | Elec-Mate E | Nakanishi, Inc. | 2001 | — |
| 0 (this device) | K083252 | Nutorque Programmable Electric System | Dentalez Group, Stardental Division | 2009 | — |
| +1 | K090937 | E-Statis 40 System | Scican, Ltd. | 2009 | — |
| +2 | K163402 | NLZ Motor System | Nakanishi, Inc. | 2017 | — |
| +3 | K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K011926 | Elec-Mate E | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090937 | E-Statis 40 System | 2009 | 2 |
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?
- Its one ancestor has no recall.
- Of its descendants, K090937 (Scican, Ltd., 2009) has gone furthest, with 2 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. 2009, 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 NuTorque Programmable Electric System is used by trained dental professionals to perform general dental procedures including crown preparation, cavity preparation, crown finishing, inlay and the filling, polishing, prophylaxis and endodontic treatment.
The device is a control unit which drives a low voltage dc electric micromotor via a handpiece hose. Power is supplied to the control unit by an ac power supply. The speed of the motor is controlled by the foot control of the dental unit. ISO E-type attachments are used to perform the various procedures. The maximum free run speed of the micromotor is 40,000 rpm's.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083252: Nutorque Programmable Electric System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083252
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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