510(k) · Cleared
ClearedComfortronic 4894 and Comfortdrive 200XDA Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaltenbach & Voigt GmbH & Co. · EIA Unit, Operative Dental
Cleared on Jun 6, 2008 as substantially equivalent to K070663 (A-Dec, Inc., 2007) and 2 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Jun 6, 2008
- Review
- 88 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K964860 (1997). 4 ancestors in all. 4 later devices descend from it, 2 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 deviceK080677 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 · 0 of its ownK180845 Maxima Electric SystemHandpiece Headquarters - Hpr, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK163317 ELECTROmaticKaltenbach & Voigt Gmgh · 2017
- Descendant · cites it directly · 0 of its ownK103697 TorqtechJ. Morita USA, Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K103027Electrotorque TLCKaltenbach & Voigt GmbH · 2011 · cites it directly2descendants
- K180845Maxima Electric SystemHandpiece Headquarters - Hpr, Inc. · 2019 · 2 generations on0descendants
- K163317ELECTROmaticKaltenbach & Voigt Gmgh · 2017 · 2 generations on0descendants
- K103697TorqtechJ. Morita USA, Inc. · 2012 · cites it directly0descendants
View 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) | K080677 | Comfortronic 4894 and Comfortdrive 200XDA Handpiece | Kaltenbach & Voigt GmbH & Co. | 2008 | — |
| +1 | K103027 | Electrotorque TLC | Kaltenbach & Voigt GmbH | 2011 | — |
| +2 | K180845 | Maxima Electric System | Handpiece Headquarters - Hpr, Inc. | 2019 | — |
| +2 | K163317 | ELECTROmatic | Kaltenbach & Voigt Gmgh | 2017 | — |
| +1 | K103697 | Torqtech | J. Morita USA, Inc. | 2012 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 EIA? 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 EIA device
- #1 K231845 Dental unit Model: Marescore 14.4 · 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? (3)
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 |
|---|---|---|---|
| * | K070663 | A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H Synea… | 2007 |
| * | K042759 | Optima MXSummary page 2…Classification Name - Operative Dental Unit and Accessories, per 21 CFR § 872.6640 Devices for Which Substantial Equivalence is Claimed: · Bien Air., Optima MX (K042759) · Sirona Dental Systems GmbH, Sirotorque L (K031584) Device Description: Th e COMFORTtronic 4894 dental control unit is a sta… | 2004 |
| * | K031584 | Sirotorque LSummary page 2…ories, per 21 CFR § 872.6640 Devices for Which Substantial Equivalence is Claimed: · Bien Air., Optima MX (K042759) · Sirona Dental Systems GmbH, Sirotorque L (K031584) Device Description: Th e COMFORTtronic 4894 dental control unit is a stand-alone system for operating electrically-driven handp… | 2003 |
What descends from it? (4)
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 11 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K103027 (Kaltenbach & Voigt GmbH, 2011) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K070663.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EIA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIA
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIA
47in 2025
MAUDE reports naming product code EIA, 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 | 3 | 90 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 3 | 109 | 0 | 0 |
| 2010 | 3 | 270 | 0 | 2 |
| 2011 | 5 | 150 | 0 | 3 |
| 2012 | 2 | — | 1 | 7 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 2 | — | 0 | 255 |
| 2015 | 7 | 214 | 0 | 452 |
| 2016 | 4 | 182 | 0 | 151 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 2 | — | 0 | 73 |
| 2019 | 2 | — | 0 | 68 |
| 2020 | 1 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 3 | 265 | 0 | 44 |
| 2023 | 3 | 686 | 0 | 53 |
| 2024 | 3 | 251 | 0 | 53 |
| 2025 | 7 | 178 | 0 | 47 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The COMFORTdrive 200XDA Handpieces are intended for the removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are designed for use by a trained professional in the field of general dentistry.
The COMFORTtronic 4894 is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. They 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/K080677 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080677: Comfortronic 4894 and Comfortdrive 200XDA Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080677
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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