510(k) Report

Devices descending from K983183

21 later devices reach Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220874Smooth Drive contra angle and straight handpiecesLares Research20220—
+1K083101Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight NoseconesSable Industries, Inc.20097—
+1K072554Access and Rotamax Fiber Optic High Speed Dental HandpiecesSable Industries, Inc.20070—
+1K031145Estylus Electric Motor SystemDentsply Intl.200310—
+2K133069Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd.20146—
+2K072989Axis SystemDentsply Intl., Inc.20088—
+2K042787IS 40 MicromotorSatelec20040—
+3K143704Advanced Air SystemW&H Dentalwerk Buermoos GmbH20157—
+3K150798Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd.20155—
+4K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd.20260—
+4K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)Nakanishi, Inc.20240—
+4K170236Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd.20174—
+4K162926Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH20176—
+5K181691High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd.20202—
+5K181858Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH20194—
+6K233288NLZ Built-In Motor SystemNakanishi, Inc.20240—
+6K231864Fiber Optic Brushless Electronic Micromotor, model: iM100Codent Technical Industry Co., Ltd.20240—
+6K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsFoshan Coxo Medical Instrument Co., Ltd.20231—
+6K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…Cefla S.C.20221—
+7K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…Foshan Soco Precision Instrument Co., Ltd.20240—
+7K230895CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3…Cefla S.C.20240—