510(k) Report

Devices descending from K012757

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+5K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+5K162390ET Hybrid AbutmentHiossen, Inc.20172—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+5K153521IH Implant SystemSewonmedix, Inc.201610—
+5K160784CAM Titanium BlanksAltatec GmbH20161—
+5K1514553Shape Abutment Designer Software3Shape A/S201610—
+5K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+5K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+5K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+5K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+5K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+5K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+5K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+6K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K233389EK Digital AbutmentsHiossen, Inc.20240—
+6K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+6K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K222707IH Implant SystemSewonmedix, Inc.20231—
+6K223663SIMDA AbutmentSimda Co., Ltd.20232—
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+6K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+6K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K220482SherlockOpen Implants, LLC20221—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+6K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+6K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+6K193352AbutmentCADExocad GmbH20210—
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K200100Abutment Design3Shape A/S20203—
+6K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+6K181932DTX Studio designNobel Biocare AB20190—
+6K171532TruBase STruabutment, Inc.20187—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+6K170421ET Hybrid AbutmentHiossen, Inc.20180—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+6K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+6K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+6K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+7K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+7K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+7K240977DenQ Sub SLA Implant SystemDenq20240—
+7K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+7K231559Multi-Unit DAS SystemTalladium España, SL20231—