510(k) Report

Devices descending from K013867

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221107TRUSTRgorithm Korea20230—
+5K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+5K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+5K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+5K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+5K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K213599SuperLineDentium Co., Ltd.20220—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K212538DESS Dental ImplantsTerrats Medical SL20211—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K211225MIS Ti-base abutmentDentsply Sirona20210—
+5K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+5K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+5K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+5K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+5K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+5K183079Conometric AbutmentsDentsply Sirona, Inc.20190—
+5K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+5K181037DIO CAD/CAM AbutmentDio Corporation20187—
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+5K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+5K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+5K172240SPI Dental Implant SystemMsi France20180—
+5K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+5K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+5K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+5K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+5K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+5K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+5K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+5K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+5K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+5K161177Axiom PXAnthogyr Sas20170—
+5K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+5K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+5K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+5K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+5K162390ET Hybrid AbutmentHiossen, Inc.20172—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K160786RODO Abutment SystemRodo Medical, Inc.20162—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+5K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+5K160784CAM Titanium BlanksAltatec GmbH20161—
+5K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+5K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+5K160244VARIOuniteThommen Medical AG201615—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K152555Dental Implant SystemAriabio International, Inc.20160—
+5K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+5K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+5K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+5K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+5K150295LOCATOR RTxZest Anchors, Inc.201542—
+5K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+5K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—