510(k) Report

Devices descending from K061701

7 later devices reach High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130560Mastertorque Lux 8900 LKaltenbach & Voigt GmbH20135—
+1K103697TorqtechJ. Morita USA, Inc.20120—
+2K173943Dental High-speed Handpiece and AccessoriesMicrop Technology (Taiwan), Inc.20180—
+2K141886MDK HandpiecesModern Korea Co., Ltd.20153—
+3K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.20260—
+3K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd.20260—
+3K202786Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc.20210—