510(k) Report

Devices descending from K013867

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+5K141450AXIOM 2.8Anthogyr Sas201401
+5K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+5K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+5K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+5K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+5K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+5K131701Z5MLB, Z5MLCZ-Systems AG20131—
+5K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+5K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+5K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+5K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K113779Conelog Implant SystemAltatec GmbH201214—
+5K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+5K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+5K121334VarioecoThommen Medical AG201216—
+5K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+5K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+6K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K232383iPhysio® SystemEuroteknika20250—
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+6K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+6K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20242—
+6K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K233389EK Digital AbutmentsHiossen, Inc.20240—
+6K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+6K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+6K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+6K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+6K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+6K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+6K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+6K223663SIMDA AbutmentSimda Co., Ltd.20232—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+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—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+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—
+6K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K220823Preat AbutmentsPreat Corporation202216
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+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—
+6K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K220022TRATE Dental Implant SystemTrate AG20221—
+6K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+6K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+6K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+6K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+6K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+6K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+6K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+6K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—