# K103027: Electrotorque TLC

- Pathway: 510(k) (Traditional)
- Applicant: Kaltenbach & Voigt GmbH
- Decided: Aug 19, 2011 after 310 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K964860 (1997). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042759: Optima MX, Bien-Air SA Switzerland (2004) Summary page 1.
- K031584: Sirotorque L, Sirona Dental Systems GmbH (2003)
- K080677: Comfortronic 4894 and Comfortdrive 200XDA Handpiece, Kaltenbach & Voigt GmbH & Co. (2008) Summary page 1.
- (no number) Kaltenbach & Voigt, COMFORTdrive 200XDA: named in the summary without a submission number
- (no number) Bien Air, Mikromotor MX: named in the summary without a submission number
- (no number) Sirona Dental Systems, motor BL ISO: named in the summary without a submission number

## Most influential descendants
- K180845: Maxima Electric System (2019), 0 descendants of its own
- K163317: ELECTROmatic (2017), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K103027
Methodology: https://510kreport.com/methodology