510(k) Report

Devices descending from K992011

12 later devices reach Synea-HS High Speed-Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043498Twin Power Turbine High Speed Air Turbine Dental HandpieceJ. Morita USA, Inc.200511—
+2K131319T1/T2/T3 Turbine FamilySirona Dental Systems GmbH20142—
+2K061701High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H)J. Morita USA, Inc.20067—
+3K203791Stainless TurbineNakanishi, Inc.20221—
+3K130560Mastertorque Lux 8900 LKaltenbach & Voigt GmbH20135—
+3K103697TorqtechJ. Morita USA, Inc.20120—
+4K230888Titanium TurbineNakanishi, Inc.20230—
+4K173943Dental High-speed Handpiece and AccessoriesMicrop Technology (Taiwan), Inc.20180—
+4K141886MDK HandpiecesModern Korea Co., Ltd.20153—
+5K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.20260—
+5K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd.20260—
+5K202786Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc.20210—