# K163317: ELECTROmatic

- Pathway: 510(k) (Traditional)
- Applicant: Kaltenbach & Voigt Gmgh
- Decided: Feb 21, 2017 after 90 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: 5 generations back to K964860 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103027: Electrotorque TLC, Kaltenbach & Voigt GmbH (2011) Summary page 4.

## Indications for use
The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy to drive the COMFORTdrive motor handpiece and the INTRA LUX KL 703 LED motor for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry

Source page: https://510kreport.com/device/K163317
Methodology: https://510kreport.com/methodology