510(k) Report

Devices descending from K990682

24 later devices reach Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092833Endomax Cordless Endodontic HandpieceDentamerica20104—
+1K092614X-Smart EasyDentsply Interntional200920—
+2K133298Endo SmartMeta Biomed, Inc.20146—
+2K123582Endo a ClassSaeyang Microtech Co., Ltd.20133—
+2K111616E-CUBESaeshin Precision Co., Ltd.201110—
+2K103653E3 Torque Control MotorDentsply International, Inc.20118—
+3K232810Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd.20230—
+3K213897Pro M ClassSaeyang Microtech Co., Ltd.20220—
+3K161213XSmart iQDentsply Sirona20172—
+3K153285EMS-200Meta Systems Co., Ltd.20165—
+3K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH20152—
+3K143411Traus EndoSaeshin Precision Co., Ltd.20151—
+3K111623I-Endo DualSatelec - Acteon Group20121—
+4K233288NLZ Built-In Motor SystemNakanishi, Inc.20240—
+4K233117Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)Nakanishi, Inc.20240—
+4K212043Traus EndoSaeshin Precision Co., Ltd.20220—
+4K202906EndoPilot2Schlumbohm GmbH & Co. KG20214—
+4K163402NLZ Motor SystemNakanishi, Inc.20171—
+4K131151EndocenterSatelec - Acteon Group20140—
+5K251701Star E900 Electric SystemDentalez, Inc., Stardental Division20260—
+5K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.20250—
+5K233865X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc.20241—
+5K213947Ultrasonic Endo Activation Device (Model:Actor I pro)Changzhou Bomedent Medical Technology Co.,Ltd20220—
+6K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.20250—