510(k) Report

Devices descending from K003271

612 later devices reach Modification to Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+4K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+4K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+4K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+4K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K212538DESS Dental ImplantsTerrats Medical SL20211—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+4K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+4K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+4K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+4K173819MyPlant II Implant SystemHager& Meisinger GmbH20183—
+4K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+4K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+4K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+4K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+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—
+4K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+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—
+4K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+4K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K162073Dental Implants OKTAGON Tissue Level and Bone LevelHager& Meisinger GmbH20170—
+4K160132Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone…Hager& Meisinger GmbH20160—
+4K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+4K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+4K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K150899Straumann CARES Titanium Alloy (TAN) AbutmentStraumann USA, LLC201511—
+4K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+4K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+4K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+4K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+4K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+4K133991ISYAltatec GmbH20142—
+4K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+4K132214Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator…Hager& Meisinger GmbH20149—
+4K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+4K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+4K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+4K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—