510(k) Report

Devices descending from K925766

565 later devices reach Branemark System Temporary Solutions through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+7K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+7K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+7K240143JDZygoma dental implantsJdentalcare Srl20240—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+7K230103Klockner AbutmentsSoadco, S.L.20230—
+7K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+7K220517IBS SystemInnobiosurg Co., Ltd.20220—
+7K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+7K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+7K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+7K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+7K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+7K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+7K213599SuperLineDentium Co., Ltd.20220—
+7K212664SherlockOpen Implants, LLC20212—
+7K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K212108Dynamic TiBaseTalladium España, SL20219—
+7K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+7K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+7K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+7K193352AbutmentCADExocad GmbH20210—
+7K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+7K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+7K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+7K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+7K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+7K200100Abutment Design3Shape A/S20203—
+7K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+7K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+7K191152MIS Ti-base AbutmentDentsply Sirona20201—
+7K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+7K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+7K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+7K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+7K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+7K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+7K181932DTX Studio designNobel Biocare AB20190—
+7K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+7K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+7K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+7K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+7K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+7K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+7K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+7K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+7K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+7K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+7K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+7K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+7K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+7K151599iSy Implant SystemAltatec GmbH20150—
+7K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+7K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+7K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+7K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+7K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+7K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+7K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+7K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+7K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+7K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+7K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+7K121117NDX AbutmentsNational Dentex Corp20120—
+7K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+7K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+8K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+8K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+8K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+8K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+8K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+8K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+8K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+8K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+8K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+8K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+8K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+8K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+8K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+8K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+8K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+8K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+8K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—