510(k) Report

Devices descending from K024004

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+6K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+6K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+6K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K230103Klockner AbutmentsSoadco, S.L.20230—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+6K213677Bonafix 2 PlusZentek Medical, LLC20220—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K220823Preat AbutmentsPreat Corporation202216
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+6K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+6K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+6K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K220022TRATE Dental Implant SystemTrate AG20221—
+6K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+6K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+6K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+6K200386Z5-BLZ-Systems AG20200—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+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—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K193335SherlockOpen Implants, LLC20203—
+6K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+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—
+6K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+6K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+6K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+6K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+6K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+6K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+6K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+6K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+6K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+6K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+6K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+6K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+6K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+6K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+6K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+6K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+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—
+6K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+6K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+6K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+6K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+6K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+6K113606NNC Gold Abutment for BridgesStraumann USA20120—
+6K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+6K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+7K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+7K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+7K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+7K240143JDZygoma dental implantsJdentalcare Srl20240—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+7K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—