510(k) · Cleared
ClearedE-Statis 40 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scican, Ltd. · EBW Controller, Foot, Handpiece And Cord
Cleared on Jul 24, 2009 as substantially equivalent to K042759 (Bien-Air SA Switzerland, 2004) and 1 other predicate after a 112-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.
- Decided
- Jul 24, 2009
- Review
- 112 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K964860 (1997). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK964860 Mark 20 and Mark 25 Hand Engine ControllerBell Intl., Inc. · 1997
- 2 generations backK031584 Sirotorque LSirona Dental Systems GmbH · 2003
- 1 generation backK042759 Optima MXBien-Air SA Switzerland · 2004
- This deviceK090937 E-Statis 40 SystemScican, Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK163402 NLZ Motor SystemNakanishi, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK251701 Star E900 Electric SystemDentalez, Inc., Stardental Division · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964860 | Mark 20 and Mark 25 Hand Engine Controller | Bell Intl., Inc. | 1997 | — |
| −2 | K031584 | Sirotorque L | Sirona Dental Systems GmbH | 2003 | — |
| −1 | K042759 | Optima MX | Bien-Air SA Switzerland | 2004 | — |
| 0 (this device) | K090937 | E-Statis 40 System | Scican, Ltd. | 2009 | — |
| +1 | K163402 | NLZ Motor System | Nakanishi, Inc. | 2017 | — |
| +2 | K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K042759 | Optima MXSummary page 1…Classification name: Dental Handpiece and Accessories Predicate Device: OPTIMA MX NuTorque 510(k) K042759 510(k) K083252 Description of Device: The E-STATIS type 40 Electric Motor System -is designed for use in various… | 2004 |
| * | K083252 | Nutorque Programmable Electric SystemSummary page 1…Dental Handpiece and Accessories Predicate Device: OPTIMA MX NuTorque 510(k) K042759 510(k) K083252 Description of Device: The E-STATIS type 40 Electric Motor System -is designed for use in various dental procedures including de… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163402 | NLZ Motor System | 2017 | 1 |
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 12 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K163402 (Nakanishi, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K042759.
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 E-STATIS 40 System is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. The system provides control for motorized handpieces by converting pneumatic output from the dental treatment center to permit the operation of electrically driven dental handpieces.
Typical users of this system are trained dental professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090937: E-Statis 40 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090937
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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