510(k) Report

Devices descending from K043310

11 later devices reach Synthes (Usa) Electric Pen Drive System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100410Piezoelectric SystemSatelec20108—
+1K093361Synthes Air Pen Drive (Apd) SystemSynthes (Usa)20100—
+1K083284Piezosurgery MedicalPiezosurgery S.R.L.20099—
+2K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium20182—
+2K163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group20170—
+2K132848Piezosurgery FlexMectron S.P.A.20136—
+3K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.20210—
+3K190281Ultrasonic Surgical SystemMedisonic Technology CO20190—
+3K153743Piezosurgery PlusMectron S.P.A.20162—
+4K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…W&H Dentalwerk Buermoos GmbH20250—
+4K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…Bennett Jacoby, Dds, Ms, Inc.20200—