510(k) Report

Devices descending from K010291

482 later devices reach Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+4K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+4K242379LL Implant SystemOssvis Co., Ltd.20240—
+4K242261Accelx Implant SystemBiotech Dental, LLC20240—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240383Highness Implant SystemHighness Co., Ltd.20240—
+4K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+4K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+4K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+4K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+4K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+4K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+4K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+4K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+4K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+4K221752StellaShinhung Mst Co., Ltd.20230—
+4K222738Point implant systemPointnix Co., Ltd.20230—
+4K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+4K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K213599SuperLineDentium Co., Ltd.20220—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K212538DESS Dental ImplantsTerrats Medical SL20211—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+4K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+4K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+4K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+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—
+4K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+4K172100URIS OMNI SystemTruabutment, Inc.20187—
+4K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+4K172240SPI Dental Implant SystemMsi France20180—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+4K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+4K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+4K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+4K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+4K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+4K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+4K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+4K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+4K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+4K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+4K153521IH Implant SystemSewonmedix, Inc.201610—
+4K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+4K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+4K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+4K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+4K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+4K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+4K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+4K131701Z5MLB, Z5MLCZ-Systems AG20131—
+4K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+4K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+4K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—