510(k) Report

Devices descending from K050393

258 later devices reach The Guided Surgery Concept through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223663SIMDA AbutmentSimda Co., Ltd.20232—
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+6K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+6K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K220823Preat AbutmentsPreat Corporation202216
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+6K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+6K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+6K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+6K191152MIS Ti-base AbutmentDentsply Sirona20201—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K193335SherlockOpen Implants, LLC20203—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+6K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+6K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K171532TruBase STruabutment, Inc.20187—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+6K170421ET Hybrid AbutmentHiossen, Inc.20180—
+6K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+6K152555Dental Implant SystemAriabio International, Inc.20160—
+6K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+6K151599iSy Implant SystemAltatec GmbH20150—
+6K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+6K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+6K133362SGS Dental ImplantSgs International, Ltd.20142—
+6K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+7K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+7K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K232271SIMDA abutmentSimda Co., Ltd.20230—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+7K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+7K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+7K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+7K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+7K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+7K220022TRATE Dental Implant SystemTrate AG20221—
+7K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+7K212664SherlockOpen Implants, LLC20212—
+7K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+7K211225MIS Ti-base abutmentDentsply Sirona20210—
+7K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+7K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+7K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+7K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+7K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+7K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+7K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+7K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+7K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+8K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—