510(k) Report

Devices descending from K003552

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K222707IH Implant SystemSewonmedix, Inc.20231—
+6K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K213677Bonafix 2 PlusZentek Medical, LLC20220—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K212664SherlockOpen Implants, LLC20212—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+6K200386Z5-BLZ-Systems AG20200—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K191123Multi-unit AbutmentsMedentika GmbH202011—
+6K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+6K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+6K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+6K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+6K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+6K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+6K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+6K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+6K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+6K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+6K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+6K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+7K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+7K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K240560ZENEX Implant System_LongIzenimplant 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—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222976MU SystemDentis Co., Ltd.20230—
+7K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+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—
+7K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220482SherlockOpen Implants, LLC20221—
+7K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+7K210039CORE1 Implant SystemCybermed, Inc.20220—
+7K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+7K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+7K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+7K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+7K200355Duranext AbutmentsElegant Dental Corp.20200—
+7K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+7K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K181037DIO CAD/CAM AbutmentDio Corporation20187—
+7K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+7K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+7K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+7K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—