510(k) Report

Devices descending from K984104

1,043 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—
+4K251280DESS® Dental ImplantsTerrats Medical SL20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+4K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+4K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+4K200102MIS Dental Implant SystemDentsply Sirona20200—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+4K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+4K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+4K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd.20200—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K191054Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd.20191—
+4K191201EM SA Implant SystemHiossen, Inc.20191—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+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
+4K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+4K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K173701Implant-One SystemImplant Logistics, Inc.20181—
+4K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+4K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+4K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+4K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+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—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+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—
+4K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+4K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+4K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+4K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K163043Zeramex P6 Dental Implant SystemDentalpoint AG20160—
+4K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc.20160—
+4K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+4K160119NobelSpeedy GroovyNobel Biocare AB20167—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+4K152845Allied Biocompat Abutment for Nobel Replace InterfaceAllied Dental Solutions20160—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+4K141188Microdent Genius Implant SystemImplant Microdent20150—
+4K142174Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20151—
+4K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+4K140934Hiossen Implant SystemHiossen, Inc.201413—
+4K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+4K133050One Plus Implant SystemOsseofuse, Inc.20141—
+4K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+4K132881Z5CZ-Systems AG20148—
+4K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+4K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—