510(k) Report

Devices descending from K031719

514 later devices reach Esthetic Zirconia Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+5K162390ET Hybrid AbutmentHiossen, Inc.20172—
+5K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+5K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+5K151599iSy Implant SystemAltatec GmbH20150—
+5K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+5K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+5K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+5K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+5K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+5K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+5K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+5K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+5K121117NDX AbutmentsNational Dentex Corp20120—
+5K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+5K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+6K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+6K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+6K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K233389EK Digital AbutmentsHiossen, Inc.20240—
+6K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+6K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+6K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+6K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+6K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K221107TRUSTRgorithm Korea20230—
+6K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+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—
+6K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K212664SherlockOpen Implants, LLC20212—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+6K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+6K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+6K211225MIS Ti-base abutmentDentsply Sirona20210—
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+6K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+6K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+6K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+6K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+6K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+6K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+6K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+6K170421ET Hybrid AbutmentHiossen, Inc.20180—
+6K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+6K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+6K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+6K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+6K160784CAM Titanium BlanksAltatec GmbH20161—
+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—
+6K120414Osseospeed PlusAstra Tech AB2012196—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+7K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+7K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K242703LW Pre-milled AbutmentOssvis Co., 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—
+7K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+7K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—