510(k) · Cleared
ClearedSirotorque L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · EBW Controller, Foot, Handpiece And Cord
Cleared on Aug 19, 2003 as substantially equivalent to K964860 (Bell Intl., Inc., 1997) after a 90-day review. Its family tree reaches back 1 generation to 1997. 13 later devices descend from it.
- Decided
- Aug 19, 2003
- Review
- 90 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964860 (1997). 13 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK964860 Mark 20 and Mark 25 Hand Engine ControllerBell Intl., Inc. · 1997
- This deviceK031584 Sirotorque LSirona Dental Systems GmbH · 2003
- Descendant · cites it directly · 11 of its ownK042759 Optima MXBien-Air SA Switzerland · 2004
- Descendant · cites it directly · 4 of its ownK080677 Comfortronic 4894 and Comfortdrive 200XDA HandpieceKaltenbach & Voigt GmbH & Co. · 2008
- Descendant · cites it directly · 2 of its ownK103027 Electrotorque TLCKaltenbach & Voigt GmbH · 2011
- Descendant · 2 generations on · 2 of its ownK090937 E-Statis 40 SystemScican, Ltd. · 2009
- Descendant · 2 generations on · 1 of its ownK201191 Elec-LedMicro-Nx Co., Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K042759Optima MXBien-Air SA Switzerland · 2004 · cites it directly11descendants
- K080677Comfortronic 4894 and Comfortdrive 200XDA HandpieceKaltenbach & Voigt GmbH & Co. · 2008 · cites it directly4descendants
- K103027Electrotorque TLCKaltenbach & Voigt GmbH · 2011 · cites it directly2descendants
- K090937E-Statis 40 SystemScican, Ltd. · 2009 · 2 generations on2descendants
- K201191Elec-LedMicro-Nx Co., Ltd. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964860 | Mark 20 and Mark 25 Hand Engine Controller | Bell Intl., Inc. | 1997 | — |
| 0 (this device) | K031584 | Sirotorque L | Sirona Dental Systems GmbH | 2003 | — |
| +1 | K042759 | Optima MX | Bien-Air SA Switzerland | 2004 | — |
| +1 | K080677 | Comfortronic 4894 and Comfortdrive 200XDA Handpiece | Kaltenbach & Voigt GmbH & Co. | 2008 | — |
| +1 | K103027 | Electrotorque TLC | Kaltenbach & Voigt GmbH | 2011 | — |
| +2 | K090937 | E-Statis 40 System | Scican, Ltd. | 2009 | — |
| +2 | K201191 | Elec-Led | Micro-Nx Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K964860 | Mark 20 and Mark 25 Hand Engine ControllerSummary page 1…Classification Name: Dental Handpiece and Accessories 3. PREDICATE DEVICES Bell International Mark 20 and Mark 25 Hand Engine Controller (K964860) 4. INTENDED USE The SiroTorque L is intended to convert pneunlatic output from a dental treatment center to el… | 1997 |
What descends from it? (13)
See all 134 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?
- Its one ancestor has no recall.
- Of its descendants, K042759 (Bien-Air SA Switzerland, 2004) has gone furthest, with 11 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 SiroTorque L is intended to convert pneumatic output from a dental treatment center to
electrical energy for operation of electrically-driven dental handpieces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031584: Sirotorque L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031584
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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