510(k) Report

Devices descending from K180282

11 later devices reach MIS Internal Hex Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+1K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+1K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+1K200102MIS Dental Implant SystemDentsply Sirona20200—
+1K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+1K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—
+1K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+2K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+2K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+2K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+2K192839DSP Implant SystemD.S.P Industrial Eireli20210—