# K080677: Comfortronic 4894 and Comfortdrive 200XDA Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Kaltenbach & Voigt GmbH & Co.
- Decided: Jun 6, 2008 after 88 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K964860 (1997). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070663: A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97,  a-Dec/W&H Synea Handpiece Attachment, A-Dec, Inc. (2007)
- K042759: Optima MX, Bien-Air SA Switzerland (2004) Summary page 2.
- K031584: Sirotorque L, Sirona Dental Systems GmbH (2003) Summary page 2.

## Most influential descendants
- K103027: Electrotorque TLC (2011), 2 descendants of its own
- K180845: Maxima Electric System (2019), 0 descendants of its own
- K163317: ELECTROmatic (2017), 0 descendants of its own
- K103697: Torqtech (2012), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K080677
Methodology: https://510kreport.com/methodology