510(k) Report

Devices descending from K080677

4 later devices reach Comfortronic 4894 and Comfortdrive 200XDA Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103697TorqtechJ. Morita USA, Inc.20120—
+1K103027Electrotorque TLCKaltenbach & Voigt GmbH20112—
+2K180845Maxima Electric SystemHandpiece Headquarters - Hpr, Inc.20190—
+2K163317ELECTROmaticKaltenbach & Voigt Gmgh20170—