510(k) Report

Devices descending from K030007

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+5K193335SherlockOpen Implants, LLC20203—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+5K191123Multi-unit AbutmentsMedentika GmbH202011—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+5K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+5K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+5K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+5K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+5K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+5K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+5K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+5K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+5K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+5K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+5K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+5K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+5K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+5K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K240977DenQ Sub SLA Implant SystemDenq20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K222976MU SystemDentis Co., Ltd.20230—
+6K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+6K210039CORE1 Implant SystemCybermed, Inc.20220—
+6K212664SherlockOpen Implants, LLC20212—
+6K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+6K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+6K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+6K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+6K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+6K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+6K200355Duranext AbutmentsElegant Dental Corp.20200—
+6K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+6K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+6K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+6K181037DIO CAD/CAM AbutmentDio Corporation20187—
+6K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+6K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+6K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+6K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+6K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+6K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+6K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+6K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+6K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+6K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+6K162390ET Hybrid AbutmentHiossen, Inc.20172—
+6K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+6K160784CAM Titanium BlanksAltatec GmbH20161—
+6K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+6K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+6K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+6K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—