510(k) Report

Devices descending from K021318

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+5K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+5K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20242—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+5K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+5K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+5K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+5K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+5K221107TRUSTRgorithm Korea20230—
+5K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K220823Preat AbutmentsPreat Corporation202216
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K221966Dynamic TiBaseTalladium Espana, SL20225—
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+5K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+5K212538DESS Dental ImplantsTerrats Medical SL20211—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K211225MIS Ti-base abutmentDentsply Sirona20210—
+5K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+5K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+5K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+5K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+5K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+5K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+5K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+5K193335SherlockOpen Implants, LLC20203—
+5K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+5K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+5K181037DIO CAD/CAM AbutmentDio Corporation20187—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—