510(k) Report

Devices descending from K012757

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K123638Pekkton IvoryCendres & Metaux SA20130—
+4K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+4K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+4K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20120—
+4K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+4K113606NNC Gold Abutment for BridgesStraumann USA20120—
+4K113410NNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC Temporary Cap for Colid…Straumann USA20121—
+4K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+4K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20111—
+4K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG2010167—
+4K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+4K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+4K082545Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG2008171—
+4K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+5K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+5K232528Protective CapNeobiotech Co., Ltd.20240—
+5K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+5K231079LW Retraction CapOssvis Co., Ltd.20230—
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+5K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+5K213677Bonafix 2 PlusZentek Medical, LLC20220—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+5K212664SherlockOpen Implants, LLC20212—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K211225MIS Ti-base abutmentDentsply Sirona20210—
+5K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+5K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K200386Z5-BLZ-Systems AG20200—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+5K191123Multi-unit AbutmentsMedentika GmbH202011—
+5K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+5K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+5K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+5K181037DIO CAD/CAM AbutmentDio Corporation20187—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+5K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+5K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+5K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+5K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+5K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—