510(k) Report

Devices descending from K010291

482 later devices reach Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+6K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+6K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+6K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+6K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+7K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+7K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K233389EK Digital AbutmentsHiossen, Inc.20240—
+7K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+7K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+7K223663SIMDA AbutmentSimda Co., Ltd.20232—
+7K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+7K220517IBS SystemInnobiosurg Co., Ltd.20220—
+7K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220482SherlockOpen Implants, LLC20221—
+7K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+7K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+7K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+7K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+7K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+7K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K170421ET Hybrid AbutmentHiossen, Inc.20180—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+8K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+8K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+8K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+8K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+8K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+9K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+9K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+9K201842TruBase STruabutment, Inc.20210—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+10K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+10K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+10K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+10K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+11K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+11K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+11K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—