510(k) · Cleared
ClearedElectrotorque TLC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaltenbach & Voigt GmbH · EBW Controller, Foot, Handpiece And Cord
Cleared on Aug 19, 2011 as substantially equivalent to K042759 (Bien-Air SA Switzerland, 2004) and 2 other predicates after a 310-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Aug 19, 2011
- Review
- 310 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K964860 (1997). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK964860 Mark 20 and Mark 25 Hand Engine ControllerBell Intl., Inc. · 1997
- 3 generations backK031584 Sirotorque LSirona Dental Systems GmbH · 2003
- 2 generations backK042759 Optima MXBien-Air SA Switzerland · 2004
- 1 generation backK080677 Comfortronic 4894 and Comfortdrive 200XDA HandpieceKaltenbach & Voigt GmbH & Co. · 2008
- This deviceK103027 Electrotorque TLCKaltenbach & Voigt GmbH · 2011
- Descendant · cites it directly · 0 of its ownK180845 Maxima Electric SystemHandpiece Headquarters - Hpr, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK163317 ELECTROmaticKaltenbach & Voigt Gmgh · 2017
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 |
|---|---|---|---|---|---|
| −4 | K964860 | Mark 20 and Mark 25 Hand Engine Controller | Bell Intl., Inc. | 1997 | — |
| −3 | K031584 | Sirotorque L | Sirona Dental Systems GmbH | 2003 | — |
| −2 | K042759 | Optima MX | Bien-Air SA Switzerland | 2004 | — |
| −1 | K080677 | Comfortronic 4894 and Comfortdrive 200XDA Handpiece | Kaltenbach & Voigt GmbH & Co. | 2008 | — |
| 0 (this device) | K103027 | Electrotorque TLC | Kaltenbach & Voigt GmbH | 2011 | — |
| +1 | K180845 | Maxima Electric System | Handpiece Headquarters - Hpr, Inc. | 2019 | — |
| +1 | K163317 | ELECTROmatic | Kaltenbach & Voigt Gmgh | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 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? (6)
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…ssories " Classification Name - Dental Handpieces and Accessories, per 21 CFR § 872.4200 Devices for Which Substantial Equivalence is Claimed: a Bien Air, Optima MX (K042 759) a Sirona Dental Systems GmbH, Sirotorque L (K031S84) * Kaltenbach & Voigt GmbH, COMFORTtronic 4894 (K080677) Device Descri… | 2004 |
| * | K031584 | Sirotorque L | 2003 |
| * | K080677 | Comfortronic 4894 and Comfortdrive 200XDA HandpieceSummary page 1…ntial Equivalence is Claimed: a Bien Air, Optima MX (K042 759) a Sirona Dental Systems GmbH, Sirotorque L (K031S84) * Kaltenbach & Voigt GmbH, COMFORTtronic 4894 (K080677) Device Description: The ELECTROtorque TLC 4893 dental control unit is a stand-alone system for operating electrically-driven… | 2008 |
| * | — | Kaltenbach & Voigt, COMFORTdrive 200XDA Named without a submission number | |
| * | — | Bien Air, Mikromotor MX Named without a submission number | |
| * | — | Sirona Dental Systems, motor BL ISO Named without a submission number |
What descends from it? (2)
2 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?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K180845 (Handpiece Headquarters - Hpr, Inc., 2019) has gone furthest, with 0 descendants 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. 2011, 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 ELECTROtorgue TLC 4893 is intended to convert pneumatic output from a dental treatment center to electrical energy to drive the INTRAmatic KL 702 motor for operation of electrically-driven dental handpieces. These devices are designed for use by a trained professional in the field of general dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103027: Electrotorque TLC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103027
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