510(k) Report

Devices descending from K112305

4 later devices reach Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141886MDK HandpiecesModern Korea Co., Ltd.20153—
+2K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.20260—
+2K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd.20260—
+2K202786Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc.20210—