510(k) Report

Devices descending from K003271

612 later devices reach Modification to Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193352AbutmentCADExocad GmbH20210—
+7K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K200100Abutment Design3Shape A/S20203—
+7K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+7K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+7K181932DTX Studio designNobel Biocare AB20190—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+7K170421ET Hybrid AbutmentHiossen, Inc.20180—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+7K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+7K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+7K132881Z5CZ-Systems AG20148—
+7K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+7K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+7K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+7K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+7K113779Conelog Implant SystemAltatec GmbH201214—
+7K120858Implant BarPrismatik Dentalcraft, Inc.20120—
+7K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216—
+7K121334VarioecoThommen Medical AG201216—
+7K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+7K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+8K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+8K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+8K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+8K240977DenQ Sub SLA Implant SystemDenq20240—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+8K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+8K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K221107TRUSTRgorithm Korea20230—
+8K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+8K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+8K222976MU SystemDentis Co., Ltd.20230—
+8K220517IBS SystemInnobiosurg Co., Ltd.20220—
+8K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+8K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+8K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB20202—
+8K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+8K201712Z5-TLZ-Systems AG20200—
+8K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+8K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+8K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+8K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+8K190243Z5-BLZ-Systems AG20202—
+8K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+8K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+8K161435Temporary Snap AbutmentNobel Biocare AB201601
+8K160244VARIOuniteThommen Medical AG201615—
+8K153779Abutment for BridgesAltatec GmbH20161—
+8K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+8K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+8K142260NobelActiveNobel Biocare AB201599—
+8K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+8K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB20250—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+9K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+9K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+9K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+9K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+9K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+9K201842TruBase STruabutment, Inc.20210—
+9K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+9K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+9K190552JJ Implant SystemJj Implants20190—
+9K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+9K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+9K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+9K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+9K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+9K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+10K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—