510(k) Report

Devices descending from K963224

329 later devices reach Steri-Oss Implants for Single Stage Placement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K142260NobelActiveNobel Biocare AB201599—
+5K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+5K133362SGS Dental ImplantSgs International, Ltd.20142—
+5K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+5K133991ISYAltatec GmbH20142—
+5K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+5K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+5K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+5K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+5K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+5K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+6K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K232383iPhysio® SystemEuroteknika20250—
+6K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB20250—
+6K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+6K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+6K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+6K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+6K233389EK Digital AbutmentsHiossen, Inc.20240—
+6K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+6K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K223663SIMDA AbutmentSimda Co., Ltd.20232—
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+6K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+6K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+6K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+6K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+6K220022TRATE Dental Implant SystemTrate AG20221—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+6K212538DESS Dental ImplantsTerrats Medical SL20211—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+6K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+6K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K193352AbutmentCADExocad GmbH20210—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+6K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+6K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+6K200100Abutment Design3Shape A/S20203—
+6K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+6K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+6K191152MIS Ti-base AbutmentDentsply Sirona20201—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+6K190552JJ Implant SystemJj Implants20190—
+6K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+6K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+6K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K183518Preat AbutmentsPreat Corporation2019223
+6K181932DTX Studio designNobel Biocare AB20190—
+6K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+6K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+6K171532TruBase STruabutment, Inc.20187—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+6K170421ET Hybrid AbutmentHiossen, Inc.20180—
+6K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+6K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+6K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+6K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+6K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+6K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+6K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+6K151599iSy Implant SystemAltatec GmbH20150—
+6K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+6K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+7K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—