510(k) Report

Devices descending from K931468

506 later devices reach Restore Hex Cylinder Endosseous System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+7K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+7K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+7K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB20202—
+7K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+7K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+7K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+7K200100Abutment Design3Shape A/S20203—
+7K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+7K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+7K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+7K191152MIS Ti-base AbutmentDentsply Sirona20201—
+7K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+7K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+7K193335SherlockOpen Implants, LLC20203—
+7K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+7K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+7K190552JJ Implant SystemJj Implants20190—
+7K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+7K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+7K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+7K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+7K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+7K182246Mist ICImagine Milling Technologies, LLC20194—
+7K181932DTX Studio designNobel Biocare AB20190—
+7K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+7K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+7K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+7K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+7K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+7K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+7K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+7K180609Rodo SmilekeyRodo Medical, Inc.20180—
+7K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+7K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+7K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+7K170394Kisses MiniAchimhai Medical Corporation20170—
+7K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+7K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+7K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+7K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+7K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+7K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+7K151599iSy Implant SystemAltatec GmbH20150—
+7K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+7K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+7K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+7K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+7K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+7K130408Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC20131—
+7K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+8K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+8K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+8K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+8K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+8K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+8K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+8K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+8K253341Custom Abutments ASMedentika GmbH20250—
+8K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+8K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+8K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+8K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K251280DESS® Dental ImplantsTerrats Medical SL20250—
+8K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+8K243824Preat AbutmentsPreat Corporation20250—
+8K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+8K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+8K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB20250—
+8K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+8K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+8K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+8K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+8K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+8K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+8K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+8K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+8K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+8K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+8K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+8K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+8K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K221107TRUSTRgorithm Korea20230—
+8K222636ET Abutment SystemHiossen, Inc.20230—
+8K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+8K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+8K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+8K222368Mist ICImagine Milling Technologies, LLC20222—
+8K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+8K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+8K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+8K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+8K213391High Retention Attachment SystemZest Anchors, LLC20227—
+8K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+8K212664SherlockOpen Implants, LLC20212—
+8K211225MIS Ti-base abutmentDentsply Sirona20210—