510(k) Report

Devices descending from K013798

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+6K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+6K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+6K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+6K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+6K223663SIMDA AbutmentSimda Co., Ltd.20232—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+6K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+6K220823Preat AbutmentsPreat Corporation202216
+6K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+6K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+6K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+6K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+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—
+6K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+6K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+6K191152MIS Ti-base AbutmentDentsply Sirona20201—
+6K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+6K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+6K193335SherlockOpen Implants, LLC20203—
+6K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+6K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+6K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+6K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K172100URIS OMNI SystemTruabutment, Inc.20187—
+6K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+6K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+6K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+6K170080Neodent Implant System - CM Pro PEEK AbutmentJjgc Industria E Comercio DE Materiais Dentarios S.A.20170—
+6K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+6K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+6K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+6K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+6K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+6K162390ET Hybrid AbutmentHiossen, Inc.20172—
+6K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+6K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+6K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+6K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+6K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+6K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+6K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+6K151599iSy Implant SystemAltatec GmbH20150—
+6K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+6K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+6K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+6K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+6K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+6K140934Hiossen Implant SystemHiossen, Inc.201413—
+6K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+6K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+6K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+6K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+6K132881Z5CZ-Systems AG20148—
+6K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+6K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+6K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+6K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+6K123638Pekkton IvoryCendres & Metaux SA20130—
+6K113779Conelog Implant SystemAltatec GmbH201214—
+6K120858Implant BarPrismatik Dentalcraft, Inc.20120—
+6K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216—
+6K121334VarioecoThommen Medical AG201216—
+6K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20120—
+6K113606NNC Gold Abutment for BridgesStraumann USA20120—
+6K113410NNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC Temporary Cap for Colid…Straumann USA20121—
+6K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20111—
+6K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+6K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+6K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+6K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+7K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—