510(k) Report

Devices descending from K100410

8 later devices reach Piezoelectric System through their predicates, nearest generation first.

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