510(k) Report

Devices descending from K143011

8 later devices reach 2014 InterActive/SwishActive System through their predicates, nearest generation first.

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