510(k) Report

Devices descending from K032158

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K132144KeratorLK Consulting Group USA, Inc.20140—
+3K131066Axiom RegAnthogyr Sas20142—
+3K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+3K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+3K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+3K120414Osseospeed PlusAstra Tech AB2012196—
+3K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+3K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+3K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+3K103280Bhdental Implant SystemBhdental, Ltd.20110—
+3K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+3K103252Camlog Vario SR AbutmentsAltatec GmbH201132—
+3K101545Genesis Implant SystemKeystone Dental2010153
+3K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+3K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+3K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+3K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+3K081851Neoss Access AbutmentsNeoss, Ltd.20090—
+3K083550Straumann Dental Implant SystemStraumann USA2009228—
+3K081419Straumann Dental Implant SystemInstitut Straumann AG2009142—
+3K083141Simpact Endosseous Dental Implant SystemSimpact, LLC20080—
+3K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+3K071803Ards Dental ImplantsArds, Ltd.200813—
+3K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+3K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+3K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG20061—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+4K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+4K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+4K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K221107TRUSTRgorithm Korea20230—
+4K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+4K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+4K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+4K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K213599SuperLineDentium Co., Ltd.20220—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K212538DESS Dental ImplantsTerrats Medical SL20211—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K211225MIS Ti-base abutmentDentsply Sirona20210—
+4K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+4K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+4K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K200355Duranext AbutmentsElegant Dental Corp.20200—
+4K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+4K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+4K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K183079Conometric AbutmentsDentsply Sirona, Inc.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+4K183518Preat AbutmentsPreat Corporation2019223