510(k) Report

Devices descending from K964860

14 later devices reach Mark 20 and Mark 25 Hand Engine Controller through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031584Sirotorque LSirona Dental Systems GmbH200313—
+2K132570Electric Handpiece SystemTtbio Corp.20140—
+2K103027Electrotorque TLCKaltenbach & Voigt GmbH20112—
+2K080677Comfortronic 4894 and Comfortdrive 200XDA HandpieceKaltenbach & Voigt GmbH & Co.20084—
+2K042759Optima MXBien-Air SA Switzerland200411—
+3K220873Perceptive electric dental motor and control unitLares Research20220—
+3K201191Elec-LedMicro-Nx Co., Ltd.20221—
+3K180845Maxima Electric SystemHandpiece Headquarters - Hpr, Inc.20190—
+3K163317ELECTROmaticKaltenbach & Voigt Gmgh20170—
+3K103697TorqtechJ. Morita USA, Inc.20120—
+3K090937E-Statis 40 SystemScican, Ltd.20092—
+4K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.20260—
+4K163402NLZ Motor SystemNakanishi, Inc.20171—
+5K251701Star E900 Electric SystemDentalez, Inc., Stardental Division20260—