510(k) Report

Devices descending from K011038

328 later devices reach Taper-Lock Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+7K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+7K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+7K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+7K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+7K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+7K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+7K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+7K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+7K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+7K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+7K211225MIS Ti-base abutmentDentsply Sirona20210—
+7K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+7K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+7K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+7K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+7K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+7K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+7K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+7K182246Mist ICImagine Milling Technologies, LLC20194—
+7K183518Preat AbutmentsPreat Corporation2019223
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+7K170421ET Hybrid AbutmentHiossen, Inc.20180—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+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—
+7K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+8K260940BellaTek BarsZimVie US Corp, LLC20260—
+8K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+8K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+8K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+8K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+8K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+8K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+8K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+8K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+8K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+8K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+8K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—
+8K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+8K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+8K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+8K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+8K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+8K222368Mist ICImagine Milling Technologies, LLC20222—
+8K220823Preat AbutmentsPreat Corporation202216
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+8K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+8K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+8K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+8K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+8K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+8K193335SherlockOpen Implants, LLC20203—
+8K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+8K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+8K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+8K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+8K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+9K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+9K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+9K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+9K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+9K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+9K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+9K243009Mist ICImagine Milling Technologies, LLC20251—
+9K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+9K243824Preat AbutmentsPreat Corporation20250—
+9K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+9K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+9K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+9K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+9K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+9K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+9K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+9K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+9K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+9K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+9K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+9K212664SherlockOpen Implants, LLC20212—
+9K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+9K212108Dynamic TiBaseTalladium España, SL20219—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+9K201842TruBase STruabutment, Inc.20210—
+10K261122Mist ICImagine Milling Technologies, LLC20260—