510(k) Report

Devices descending from K042434

22 later devices reach Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043408Piezosurgery DevicePiezosurgery S.R.L.200521—
+2K110881Ultrasonic Surgical UnitDong IL Technology, Ltd.20111—
+2K083284Piezosurgery MedicalPiezosurgery S.R.L.20099—
+2K083569SurgyboneSilfradent S.R.L.20090—
+2K072146Ems Piezon Master SurgeryE.M.S Electro Medical Systems S.A20076—
+2K060274PiezotomeSatelec200610—
+3K150076Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800LDong IL Technology, Ltd.20150—
+3K132848Piezosurgery FlexMectron S.P.A.20136—
+3K121620Ultrasonic SurgeryDmetec.Co., Ltd.20122—
+3K113152Ultrasonic Surgery MachineDmetec.Co., Ltd.20122—
+3K100410Piezoelectric SystemSatelec20108—
+3K091331Piezotome 2Satelec20091—
+4K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…Bennett Jacoby, Dds, Ms, Inc.20200—
+4K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium20182—
+4K163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group20170—
+4K153743Piezosurgery PlusMectron S.P.A.20162—
+4K151171Traus SUS10Saeshin Precision Co., Ltd.20151—
+4K131674Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+5K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…W&H Dentalwerk Buermoos GmbH20250—
+5K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.20210—
+5K192561Traus SUS20Saeshin Precision Co., Ltd.20200—
+5K190281Ultrasonic Surgical SystemMedisonic Technology CO20190—