510(k) Report

Devices descending from K020096

516 later devices reach Esthetic Ease Abutments for the Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+7K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+7K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+7K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB20250—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+7K240143JDZygoma dental implantsJdentalcare Srl20240—
+7K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+7K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+7K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+7K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+7K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222707IH Implant SystemSewonmedix, Inc.20231—
+7K222636ET Abutment SystemHiossen, Inc.20230—
+7K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+7K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+7K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+7K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+7K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+7K220482SherlockOpen Implants, LLC20221—
+7K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+7K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+7K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+7K193352AbutmentCADExocad GmbH20210—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+7K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+7K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+7K200100Abutment Design3Shape A/S20203—
+7K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+7K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+7K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+7K190552JJ Implant SystemJj Implants20190—
+7K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+7K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+7K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+7K181932DTX Studio designNobel Biocare AB20190—
+7K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+7K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+7K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+7K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+7K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+7K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+7K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+7K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+7K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+7K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+8K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+8K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+8K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+8K240977DenQ Sub SLA Implant SystemDenq20240—
+8K241032BellaTek BarsBiomet 3i, LLC20241—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+8K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+8K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+8K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+8K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+8K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+8K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+8K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+8K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+8K221107TRUSTRgorithm Korea20230—
+8K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+8K222976MU SystemDentis Co., Ltd.20230—
+8K220517IBS SystemInnobiosurg Co., Ltd.20220—
+8K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+8K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+8K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+8K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+8K201842TruBase STruabutment, Inc.20210—
+8K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+8K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+8K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+8K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+8K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+8K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+8K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+8K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+8K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+8K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+9K260940BellaTek BarsZimVie US Corp, LLC20260—