510(k) Report

Devices descending from K020833

14 later devices reach Boyd Delivery Unit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040529Cocoon HygienistSatelec200413—
+2K072030Implant CenterSatelec - Acteon Group200712—
+3K091252Implant Center 2Satelec200911—
+4K112188Piezotome SoloSatelec - Acteon, Inc.20121—
+4K100410Piezoelectric SystemSatelec20108—
+5K172137Piezotome CubeSatelec - Acteon Group20180—
+5K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium20182—
+5K163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group20170—
+5K132848Piezosurgery FlexMectron S.P.A.20136—
+6K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.20210—
+6K190281Ultrasonic Surgical SystemMedisonic Technology CO20190—
+6K153743Piezosurgery PlusMectron S.P.A.20162—
+7K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…W&H Dentalwerk Buermoos GmbH20250—
+7K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…Bennett Jacoby, Dds, Ms, Inc.20200—