510(k) Report

Devices descending from K013798

575 later devices reach Prosthetic Accessories to the Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222636ET Abutment SystemHiossen, Inc.20230—
+8K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+8K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+8K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+8K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+8K221966Dynamic TiBaseTalladium Espana, SL20225—
+8K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+8K220482SherlockOpen Implants, LLC20221—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+8K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+8K193352AbutmentCADExocad GmbH20210—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+8K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+8K200100Abutment Design3Shape A/S20203—
+8K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+8K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+8K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+8K190552JJ Implant SystemJj Implants20190—
+8K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+8K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+8K181932DTX Studio designNobel Biocare AB20190—
+8K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+8K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+8K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+8K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+8K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+8K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+8K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+9K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+9K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+9K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+9K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+9K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+9K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+9K240977DenQ Sub SLA Implant SystemDenq20240—
+9K241032BellaTek BarsBiomet 3i, LLC20241—
+9K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+9K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+9K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+9K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+9K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+9K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+9K231559Multi-Unit DAS SystemTalladium España, SL20231—
+9K232151Dynamic TiBaseTalladium España, SL20232—
+9K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+9K221107TRUSTRgorithm Korea20230—
+9K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+9K222976MU SystemDentis Co., Ltd.20230—
+9K220517IBS SystemInnobiosurg Co., Ltd.20220—
+9K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+9K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+9K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+9K201842TruBase STruabutment, Inc.20210—
+9K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+9K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+9K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+9K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+10K260940BellaTek BarsZimVie US Corp, LLC20260—
+10K243732Multi-Unit DAS SystemTalladium España, SL20260—
+10K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+10K243530Dynamic TiBaseTalladium España, SL20250—
+10K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+10K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+10K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+10K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+11K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+11K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+11K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—