510(k) Report

Devices descending from K021318

547 later devices reach Xive Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+6K231559Multi-Unit DAS SystemTalladium España, SL20231—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K232151Dynamic TiBaseTalladium España, SL20232—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K223663SIMDA AbutmentSimda Co., Ltd.20232—
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K230103Klockner AbutmentsSoadco, S.L.20230—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+6K213677Bonafix 2 PlusZentek Medical, LLC20220—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K213391High Retention Attachment SystemZest Anchors, LLC20227—
+6K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+6K212664SherlockOpen Implants, LLC20212—
+6K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+6K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+6K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+6K200386Z5-BLZ-Systems AG20200—
+6K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K191123Multi-unit AbutmentsMedentika GmbH202011—
+6K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+6K171532TruBase STruabutment, Inc.20187—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+6K170421ET Hybrid AbutmentHiossen, Inc.20180—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+6K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+6K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+6K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+6K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K243732Multi-Unit DAS SystemTalladium España, SL20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+7K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+7K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+7K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+7K243530Dynamic TiBaseTalladium España, SL20250—
+7K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+7K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K232271SIMDA abutmentSimda Co., Ltd.20230—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+7K222976MU SystemDentis Co., Ltd.20230—
+7K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+7K220482SherlockOpen Implants, LLC20221—