510(k) Report

Devices descending from K032263

476 later devices reach 3I Patient-Specific Dental Abutment and Overdenture Bar through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+5K190552JJ Implant SystemJj Implants20190—
+5K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+5K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K181932DTX Studio designNobel Biocare AB20190—
+5K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+5K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+5K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+5K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+5K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+5K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+5K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+5K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+5K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+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—
+5K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+5K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+5K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+5K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+5K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+5K121117NDX AbutmentsNational Dentex Corp20120—
+5K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+6K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+6K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K232383iPhysio® SystemEuroteknika20250—
+6K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB20250—
+6K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+6K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+6K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+6K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+6K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+6K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+6K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+6K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+6K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+6K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+6K221107TRUSTRgorithm Korea20230—
+6K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+6K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+6K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K220823Preat AbutmentsPreat Corporation202216
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K211225MIS Ti-base abutmentDentsply Sirona20210—
+6K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+6K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+6K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+6K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K193335SherlockOpen Implants, LLC20203—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+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—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+6K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+6K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+6K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+6K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+6K162390ET Hybrid AbutmentHiossen, Inc.20172—