510(k) Report

Devices descending from K030007

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K240143JDZygoma dental implantsJdentalcare Srl20240—
+4K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+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—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+4K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+4K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+4K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+4K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+4K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+4K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+4K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+4K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+4K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+4K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+4K221752StellaShinhung Mst Co., Ltd.20230—
+4K222738Point implant systemPointnix Co., Ltd.20230—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.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—
+4K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+4K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+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—
+4K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+4K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+4K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+4K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+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—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+4K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+4K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+4K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+4K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+4K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+4K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+4K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+4K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+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—
+4K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+4K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+4K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+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—