510(k) Report

Devices descending from K033243

514 later devices reach Iti Synocta Meso Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+4K220823Preat AbutmentsPreat Corporation202216
+4K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+4K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+4K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+4K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+4K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+4K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+4K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+4K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+4K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+4K191152MIS Ti-base AbutmentDentsply Sirona20201—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+4K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+4K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+4K193335SherlockOpen Implants, LLC20203—
+4K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+4K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+4K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+4K172100URIS OMNI SystemTruabutment, Inc.20187—
+4K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+4K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+4K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+4K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+4K170080Neodent Implant System - CM Pro PEEK AbutmentJjgc Industria E Comercio DE Materiais Dentarios S.A.20170—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+4K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+4K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+4K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+4K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+4K162390ET Hybrid AbutmentHiossen, Inc.20172—
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+4K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K151599iSy Implant SystemAltatec GmbH20150—
+4K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+4K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+4K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+4K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+4K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K140934Hiossen Implant SystemHiossen, Inc.201413—
+4K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+4K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+4K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+4K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+4K132881Z5CZ-Systems AG20148—
+4K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+4K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+4K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+4K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+4K123638Pekkton IvoryCendres & Metaux SA20130—
+4K113779Conelog Implant SystemAltatec GmbH201214—
+4K120858Implant BarPrismatik Dentalcraft, Inc.20120—
+4K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216—
+4K121334VarioecoThommen Medical AG201216—
+4K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20120—
+4K113606NNC Gold Abutment for BridgesStraumann USA20120—
+4K113410NNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC Temporary Cap for Colid…Straumann USA20121—
+4K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20111—
+4K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+4K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+4K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+4K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+5K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+5K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.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—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—