510(k) Report

Devices descending from K984104

1,043 later devices reach Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+7K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+7K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+7K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+7K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+7K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+7K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+7K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+7K240977DenQ Sub SLA Implant SystemDenq20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+7K233389EK Digital AbutmentsHiossen, Inc.20240—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K231559Multi-Unit DAS SystemTalladium España, SL20231—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K232151Dynamic TiBaseTalladium España, SL20232—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+7K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+7K222792SNUCONE Tissue Level Implant SystemSnucone Co., Ltd.20232—
+7K223663SIMDA AbutmentSimda Co., Ltd.20232—
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K230103Klockner AbutmentsSoadco, S.L.20230—
+7K212394Implant-One Multi-Unit AbutmentImplant Logistics, Inc.20230—
+7K222976MU SystemDentis Co., Ltd.20230—
+7K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+7K220517IBS SystemInnobiosurg Co., Ltd.20220—
+7K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+7K220339Esthetic Abutments Nobel Biocare N1Nobel Biocare Services AG20220—
+7K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+7K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+7K220482SherlockOpen Implants, LLC20221—
+7K213391High Retention Attachment SystemZest Anchors, LLC20227—
+7K200193Kisses Plus Implant SystemAchimhai Medical Corporation20210—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K193352AbutmentCADExocad GmbH20210—
+7K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+7K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB20202—
+7K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+7K200100Abutment Design3Shape A/S20203—
+7K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+7K201981Magicore SystemInnobiosurg Co., Ltd.20204—
+7K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+7K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+7K191152MIS Ti-base AbutmentDentsply Sirona20201—
+7K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+7K192197Magicore II SystemInnobiosurg Co., Ltd.20203—
+7K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+7K192263UCLA CCM AbutmentDio Corporation20204—
+7K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+7K190552JJ Implant SystemJj Implants20190—
+7K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K183079Conometric AbutmentsDentsply Sirona, Inc.20190—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+7K181932DTX Studio designNobel Biocare AB20190—
+7K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+7K170421ET Hybrid AbutmentHiossen, Inc.20180—
+7K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+7K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K170372SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc.20178—
+7K161416Multi-unit Abutment PlusNobel Biocare AB201774—
+7K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+7K1516084plus6Line Abutment SystemOt Medical GmbH20160—
+7K143142JDENTALCARE Implant SystemJdentalcare Srl20152—
+7K150968TRU Dental Implant SystemSterngold Dental, LLC20150—
+7K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+7K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+7K123627ET Smartfit AbutmentHiossen, Inc.201321—
+7K123755Multi Angled AbutmentOsstem Implant Co., Ltd.201347—
+7K121047Hero II Dental Implant System, IS Dental Implant SystemKj Meditech Co., Ltd.201214—
+7K120951Smartbuilder SystemOsstem Implant Co., Ltd.201214—
+7K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+7K113554Cmi Implant IS SystemNeobiotech Co., Ltd.201234—
+7K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—
+7K111120CSM Submerged-R Implant SystemCsm Implant20118—
+7K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+7K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+7K101732Astra Tech Implant SystemAstra Tech AB2011214—
+7K100850Cowell Implant SystemCowellmedi Co., Ltd.20104—
+7K102436Nobel Active 3.0Nobel Biocare AB2010203—