510(k) Report

Devices descending from K133298

6 later devices reach Endo Smart through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153285EMS-200Meta Systems Co., Ltd.20165—
+2K202906EndoPilot2Schlumbohm GmbH & Co. KG20214—
+3K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.20250—
+3K233865X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc.20241—
+3K213947Ultrasonic Endo Activation Device (Model:Actor I pro)Changzhou Bomedent Medical Technology Co.,Ltd20220—
+4K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.20250—