510(k) Report

Devices descending from K130572

10 later devices reach Interactive/ SWISHPLUS2 Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+1K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+1K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+2K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+3K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+3K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—