510(k) Report

Devices descending from K062129

434 later devices reach P.0004 Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+4K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+4K153521IH Implant SystemSewonmedix, Inc.201610—
+4K160784CAM Titanium BlanksAltatec GmbH20161—
+4K1514553Shape Abutment Designer Software3Shape A/S201610—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+4K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+4K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+4K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+4K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+5K261122Mist ICImagine Milling Technologies, LLC20260—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+5K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+5K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+5K233389EK Digital AbutmentsHiossen, Inc.20240—
+5K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+5K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+5K221673Bonafix TiBaseZentek Medical, LLC20231—
+5K222707IH Implant SystemSewonmedix, Inc.20231—
+5K223663SIMDA AbutmentSimda Co., Ltd.20232—
+5K222636ET Abutment SystemHiossen, Inc.20230—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+5K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K221966Dynamic TiBaseTalladium Espana, SL20225—
+5K220482SherlockOpen Implants, LLC20221—
+5K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K193352AbutmentCADExocad GmbH20210—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K192742Straumann Variobase CInstitut Straumann AG20211—
+5K200100Abutment Design3Shape A/S20203—
+5K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+5K181932DTX Studio designNobel Biocare AB20190—
+5K171532TruBase STruabutment, Inc.20187—
+5K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+5K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K170421ET Hybrid AbutmentHiossen, Inc.20180—
+5K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+5K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+5K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+5K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+5K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+6K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+6K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+6K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+6K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K250967SherlockOpen Implants, LLC20250—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K240977DenQ Sub SLA Implant SystemDenq20240—
+6K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+6K231559Multi-Unit DAS SystemTalladium España, SL20231—
+6K232271SIMDA abutmentSimda Co., Ltd.20230—
+6K232151Dynamic TiBaseTalladium España, SL20232—
+6K221107TRUSTRgorithm Korea20230—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+6K222976MU SystemDentis Co., Ltd.20230—
+6K220517IBS SystemInnobiosurg Co., Ltd.20220—
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—