510(k) Report

Devices descending from K053384

528 later devices reach Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222976MU SystemDentis Co., Ltd.20230—
+6K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K220482SherlockOpen Implants, LLC20221—
+6K220252High Retention Attachment SystemZest Anchors, LLC20221—
+6K211225MIS Ti-base abutmentDentsply Sirona20210—
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K200355Duranext AbutmentsElegant Dental Corp.20200—
+6K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+6K181037DIO CAD/CAM AbutmentDio Corporation20187—
+6K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+6K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+6K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+6K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+6K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+6K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+6K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+6K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+6K162390ET Hybrid AbutmentHiossen, Inc.20172—
+6K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+6K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K160784CAM Titanium BlanksAltatec GmbH20161—
+6K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+6K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+6K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+6K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+6K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+6K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+6K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+6K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+6K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+6K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+6K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+7K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+7K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+7K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+7K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+7K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+7K233389EK Digital AbutmentsHiossen, Inc.20240—
+7K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+7K232528Protective CapNeobiotech Co., Ltd.20240—
+7K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+7K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+7K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+7K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+7K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+7K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+7K231079LW Retraction CapOssvis Co., Ltd.20230—
+7K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+7K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+7K223663SIMDA AbutmentSimda Co., Ltd.20232—
+7K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+7K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+7K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+7K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+7K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+7K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K170421ET Hybrid AbutmentHiossen, Inc.20180—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+7K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+7K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+8K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+8K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+8K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—
+8K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+8K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+8K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K210039CORE1 Implant SystemCybermed, Inc.20220—
+8K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+8K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+8K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+8K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—