510(k) Report

Devices descending from K070663

45 later devices reach A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181858Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH20194—
+1K162926Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH20176—
+1K143465MASTERmatic LUXKaltenbach & Voigt GmbH20154—
+1K133069Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd.20146—
+1K121901TI-Max Z45Nakanishi, Inc.20130—
+1K073478Supertorque High-Speed Handpieces and Gentlepower Handpieces and AttachementsSybron Dental Specialties, Inc.200823—
+1K080677Comfortronic 4894 and Comfortdrive 200XDA HandpieceKaltenbach & Voigt GmbH & Co.20084—
+2K233288NLZ Built-In Motor SystemNakanishi, Inc.20240—
+2K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)Nakanishi, Inc.20240—
+2K231864Fiber Optic Brushless Electronic Micromotor, model: iM100Codent Technical Industry Co., Ltd.20240—
+2K220874Smooth Drive contra angle and straight handpiecesLares Research20220—
+2K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…Cefla S.C.20221—
+2K163239SMARTmaticKaltenbach & Voigt GmbH20173—
+2K150798Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd.20155—
+2K141221Lares Ultralite Prostyle High-Speed Dental Handpieces, Lares Euro Prostyle High-Speed…Lares Research, Inc.20140—
+2K130560Mastertorque Lux 8900 LKaltenbach & Voigt GmbH20135—
+2K103697TorqtechJ. Morita USA, Inc.20120—
+2K103027Electrotorque TLCKaltenbach & Voigt GmbH20112—
+2K102517Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp.201113—
+2K093341Century Model 105CSybron Dental Specialties, Inc.20100—
+3K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd.20260—
+3K230895CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3…Cefla S.C.20240—
+3K192809Dental HandpieceMicro-Nx Co., Ltd.20202—
+3K180845Maxima Electric SystemHandpiece Headquarters - Hpr, Inc.20190—
+3K173943Dental High-speed Handpiece and AccessoriesMicrop Technology (Taiwan), Inc.20180—
+3K170236Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd.20174—
+3K163317ELECTROmaticKaltenbach & Voigt Gmgh20170—
+3K152146High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd.20158—
+3K141886MDK HandpiecesModern Korea Co., Ltd.20153—
+3K113655TI-Max X TurbineNakanishi, Inc.20123—
+4K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.20260—
+4K233122High Speed Air Turbine Handpiece…Litu Tech, Ltd.20240—
+4K220577Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd.20221—
+4K202786Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc.20210—
+4K193264Disposable High Speed Air Turbine HandpieceNingbo Hpdove Dental Instruments Co., Ltd.20200—
+4K181691High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd.20202—
+4K172543High-speed Turbine Handpieces for Single UseBeijing Dongbo Dental Handpiece Co., Ltd.20180—
+4K170229Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd.20174—
+4K131319T1/T2/T3 Turbine FamilySirona Dental Systems GmbH20142—
+5K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.20260—
+5K232810Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd.20230—
+5K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsFoshan Coxo Medical Instrument Co., Ltd.20231—
+5K203791Stainless TurbineNakanishi, Inc.20221—
+6K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…Foshan Soco Precision Instrument Co., Ltd.20240—
+6K230888Titanium TurbineNakanishi, Inc.20230—