510(k) Report

Devices descending from K012473

266 later devices reach Vident Hextop, Synocta in-Ceram Blank/Coping Manufactured by Vident through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K193352AbutmentCADExocad GmbH20210—
+6K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K200100Abutment Design3Shape A/S20203—
+6K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+6K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+6K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+6K191152MIS Ti-base AbutmentDentsply Sirona20201—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K183518Preat AbutmentsPreat Corporation2019223
+6K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+6K181932DTX Studio designNobel Biocare AB20190—
+6K171532TruBase STruabutment, Inc.20187—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+6K170421ET Hybrid AbutmentHiossen, Inc.20180—
+6K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+6K151599iSy Implant SystemAltatec GmbH20150—
+6K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+6K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+6K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+7K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K231566ICX-Implant SystemMedentis Medical GmbH20240—
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+7K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+7K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+7K232271SIMDA abutmentSimda Co., Ltd.20230—
+7K221107TRUSTRgorithm Korea20230—
+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—
+7K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+7K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K220823Preat AbutmentsPreat Corporation202216
+7K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+7K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+7K211225MIS Ti-base abutmentDentsply Sirona20210—
+7K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+7K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+7K193335SherlockOpen Implants, LLC20203—
+7K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+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—
+7K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+7K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+7K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+7K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+7K152555Dental Implant SystemAriabio International, Inc.20160—
+7K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+7K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+7K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+7K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+7K133362SGS Dental ImplantSgs International, Ltd.20142—
+7K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+8K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+8K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+8K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+8K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K243824Preat AbutmentsPreat Corporation20250—
+8K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+8K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+8K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+8K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—