510(k) Report

Devices descending from K050895

11 later devices reach Surpasson P5 Newtron through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202906EndoPilot2Schlumbohm GmbH & Co. KG20214—
+1K132322Newtron P5 XS B.LedSatelec - Acteon Group20140—
+1K132267Newtron P5, Newtron P5 B.LedSatelec - Acteon Group20140—
+1K131151EndocenterSatelec - Acteon Group20140—
+1K131997Newtron BoosterSatelec - Acteon Group20130—
+1K071424Pmax Newtron XSSatelec - Acteon Group20072—
+1K060275PiezotomeSatelec20060—
+2K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.20250—
+2K233865X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc.20241—
+2K213947Ultrasonic Endo Activation Device (Model:Actor I pro)Changzhou Bomedent Medical Technology Co.,Ltd20220—
+3K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.20250—