510(k) · Cleared
ClearedMark 20 and Mark 25 Hand Engine Controller
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bell Intl., Inc. · EBW Controller, Foot, Handpiece And Cord
Cleared on Mar 3, 1997 after an 89-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Mar 3, 1997
- Review
- 89 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK964860 Mark 20 and Mark 25 Hand Engine ControllerBell Intl., Inc. · 1997
- Descendant · cites it directly · 13 of its ownK031584 Sirotorque LSirona Dental Systems GmbH · 2003
- Descendant · 2 generations on · 11 of its ownK042759 Optima MXBien-Air SA Switzerland · 2004
- Descendant · 2 generations on · 4 of its ownK080677 Comfortronic 4894 and Comfortdrive 200XDA HandpieceKaltenbach & Voigt GmbH & Co. · 2008
- Descendant · 2 generations on · 2 of its ownK103027 Electrotorque TLCKaltenbach & Voigt GmbH · 2011
- Descendant · 3 generations on · 2 of its ownK090937 E-Statis 40 SystemScican, Ltd. · 2009
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K031584Sirotorque LSirona Dental Systems GmbH · 2003 · cites it directly13descendants
- K042759Optima MXBien-Air SA Switzerland · 2004 · 2 generations on11descendants
- K080677Comfortronic 4894 and Comfortdrive 200XDA HandpieceKaltenbach & Voigt GmbH & Co. · 2008 · 2 generations on4descendants
- K103027Electrotorque TLCKaltenbach & Voigt GmbH · 2011 · 2 generations on2descendants
- K090937E-Statis 40 SystemScican, Ltd. · 2009 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964860 | Mark 20 and Mark 25 Hand Engine Controller | Bell Intl., Inc. | 1997 | — |
| +1 | K031584 | Sirotorque L | Sirona Dental Systems GmbH | 2003 | — |
| +2 | K042759 | Optima MX | Bien-Air SA Switzerland | 2004 | — |
| +2 | K080677 | Comfortronic 4894 and Comfortdrive 200XDA Handpiece | Kaltenbach & Voigt GmbH & Co. | 2008 | — |
| +2 | K103027 | Electrotorque TLC | Kaltenbach & Voigt GmbH | 2011 | — |
| +3 | K090937 | E-Statis 40 System | Scican, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | 25-D hand engine and C-310 Console (Controller) Named without a submission number |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031584 | Sirotorque L | 2003 | 13 |
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, K031584 (Sirona Dental Systems GmbH, 2003) has gone furthest, with 13 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?
Engine, power supply and controller for dental handpiece
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/K964860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964860: Mark 20 and Mark 25 Hand Engine Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964860
Report an extraction error
Are you the manufacturer?
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