510(k) Report

Devices descending from K163634

13 later devices reach External Hex Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+1K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+1K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+1K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+1K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+1K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+1K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+1K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+2K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+2K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+2K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+2K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+2K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—