510(k) Report

Devices descending from K002475

596 later devices reach Replace TPS Coated Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+6K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+6K073486Dentis Dental Implant SystemDentis Co., Ltd.200825—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K243732Multi-Unit DAS SystemTalladium España, SL20260—
+7K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+7K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+7K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+7K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+7K243530Dynamic TiBaseTalladium España, SL20250—
+7K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K242261Accelx Implant SystemBiotech Dental, LLC20240—
+7K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+7K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+7K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+7K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+7K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+7K222976MU SystemDentis Co., Ltd.20230—
+7K220482SherlockOpen Implants, LLC20221—
+7K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+7K220252High Retention Attachment SystemZest Anchors, LLC20221—
+7K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+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—
+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—
+7K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+7K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+7K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+7K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+7K181932DTX Studio designNobel Biocare AB20190—
+7K170732Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20180—
+7K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+7K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+7K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+7K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+7K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+7K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+7K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+7K160213s-Clean Tapered II RBM Implant SystemDentis Co., Ltd.20160—
+7K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+7K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+7K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+7K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+7K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+7K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+7K150344Dentis Dental Implant SystemDentis Co., Ltd.201520—
+7K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+7K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+7K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+7K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+7K130408Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC20131—
+7K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+7K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+8K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+8K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.20250—
+8K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+8K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+8K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+8K240383Highness Implant SystemHighness Co., Ltd.20240—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+8K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+8K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+8K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+8K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+8K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+8K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+8K221107TRUSTRgorithm Korea20230—
+8K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—