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
+6K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+6K231079LW Retraction CapOssvis Co., Ltd.20230—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+6K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K212664SherlockOpen Implants, LLC20212—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K211225MIS Ti-base abutmentDentsply Sirona20210—
+6K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+6K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K200355Duranext AbutmentsElegant Dental Corp.20200—
+6K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K191123Multi-unit AbutmentsMedentika GmbH202011—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+6K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+6K181037DIO CAD/CAM AbutmentDio Corporation20187—
+6K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+6K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+6K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+6K162848Straumann CARES Golden Ti/TiN AbutmentsInstitut Straumann AG20170—
+6K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+6K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+6K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+6K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+6K162390ET Hybrid AbutmentHiossen, Inc.20172—
+6K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+6K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+6K153521IH Implant SystemSewonmedix, Inc.201610—
+6K160784CAM Titanium BlanksAltatec GmbH20161—
+6K1514553Shape Abutment Designer Software3Shape A/S201610—
+6K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+6K151439Atlantis IsusDentsply International, Inc.20160—
+6K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+6K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+6K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+6K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+6K132749Nobelprocera Overdenture BarNobel Biocare USA, LLC20140—
+6K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+6K122424Isus Implant SuprastructuresDentsply International, Inc.201313—
+6K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+6K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+6K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+6K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+6K103252Camlog Vario SR AbutmentsAltatec GmbH201132—
+6K091848Nobel/Procera Implant BridgeNobel Biocare AB20091—
+6K091907Nobelprocera Implant Bridge ZirconiaNobel Biocare AB20095—
+6K091904Nobelprocera ZI AbutmentNobel Biocare AB200935—
+6K091756Nobelprocera TI AbutmentNobel Biocare AB2009278—
+7K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+7K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K233389EK Digital AbutmentsHiossen, Inc.20240—
+7K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+7K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+7K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+7K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222707IH Implant SystemSewonmedix, Inc.20231—
+7K223663SIMDA AbutmentSimda Co., Ltd.20232—
+7K222636ET Abutment SystemHiossen, Inc.20230—
+7K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+7K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+7K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+7K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+7K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220482SherlockOpen Implants, LLC20221—
+7K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+7K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+7K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+7K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+7K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—