510(k) Report

Devices descending from K071453

19 later devices reach Spi Easy 4.0 Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121334VarioecoThommen Medical AG201216—
+1K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+1K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+2K171795Thommen Implant SystemThommen Medical AG20170—
+2K160244VARIOuniteThommen Medical AG201615—
+3K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—