510(k) Report

Devices descending from K072642

256 later devices reach Biomet 3I Dental Abutments and Restorative Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+4K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K170421ET Hybrid AbutmentHiossen, Inc.20180—
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+4K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+4K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+4K160784CAM Titanium BlanksAltatec GmbH20161—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+4K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+4K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+4K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+5K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+5K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+5K223663SIMDA AbutmentSimda Co., Ltd.20232—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+5K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K220823Preat AbutmentsPreat Corporation202216
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K192742Straumann Variobase CInstitut Straumann AG20211—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K193335SherlockOpen Implants, LLC20203—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K171532TruBase STruabutment, Inc.20187—
+5K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+5K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K232271SIMDA abutmentSimda Co., Ltd.20230—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—