510(k) Report

Devices descending from K022859

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K243732Multi-Unit DAS SystemTalladium España, SL20260—
+7K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+7K243530Dynamic TiBaseTalladium España, SL20250—
+7K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+7K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+7K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+7K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+7K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+7K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+7K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+7K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K232528Protective CapNeobiotech Co., Ltd.20240—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+7K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+7K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+7K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+7K232271SIMDA abutmentSimda Co., Ltd.20230—
+7K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K231079LW Retraction CapOssvis Co., Ltd.20230—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+7K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+7K221107TRUSTRgorithm Korea20230—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+7K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+7K222976MU SystemDentis Co., Ltd.20230—
+7K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+7K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+7K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+7K220482SherlockOpen Implants, LLC20221—
+7K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+7K220252High Retention Attachment SystemZest Anchors, LLC20221—
+7K220022TRATE Dental Implant SystemTrate AG20221—
+7K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+7K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+7K211225MIS Ti-base abutmentDentsply Sirona20210—
+7K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+7K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+7K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+7K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+7K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+7K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+7K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+7K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+7K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+7K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+7K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+7K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+7K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+7K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+7K153521IH Implant SystemSewonmedix, Inc.201610—
+7K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+7K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+7K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+8K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+8K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+8K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+8K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+8K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+8K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+8K240143JDZygoma dental implantsJdentalcare Srl20240—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+8K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+8K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+8K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K222707IH Implant SystemSewonmedix, Inc.20231—
+8K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+8K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+8K201842TruBase STruabutment, Inc.20210—
+8K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+8K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+8K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+8K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+8K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+9K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—