510(k) Report

Devices descending from K101612

6 later devices reach Zen Cordless Prophy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110753Midwest RDH Freedom Cordless Prophy SystemDentsply International, Inc.20115—
+2K171377Young INFINITY Cordless Handpiece SystemYoung Dental Manufacturing Co. 1, LLC20182—
+2K160825MIDWEST RDH Freedom Cordless Prophy System with SmartMode TechnologyDentsply Sirona20160—
+2K131578Iprophy MobileNakanishi, Inc.20130—
+3K211531Cordless Prophy System, Model: i-PolishGuilin Woodpecker Medical Instrument Co., Ltd.20210—
+3K201703PROXEO Twist Cordless Polishing System PL-40 HW&H Dentalwerk Buermoos GmbH20210—