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    K Number
    K253334

    Validate with FDA (Live)

    Device Name
    ZENEX Implant System_Short (R-System)
    Manufacturer
    Izenimplant Co., Ltd.
    Date Cleared
    2026-03-16

    (167 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K211090,K252585,K233163
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K211090, K252585

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ZENEX Implant System_Short(R-System) is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture system is intended to be used in the molar region.

    Short and Wide implants must be splinted to adjacent implants in areas of poor bone quality or high occlusal forces.

    Device Description

    ZENEX Implant System_Short (R-System) is a thread type implant made of pure titanium according to ASTM F67 and supplied sterile, which will be placed in the alveolar bone in order to support or maintain the prosthetic tooth or denture when a patient's teeth are partially or totally lost.

    The fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). The entire length of 6.25mm of implant bodies are implanted into the bone to connect prosthetic devices of a dental implant set with the human body (mandibular or maxillary bone).

    There is a type of fixture, and the dimensions are as follows:

    NameFixture TypeDiameter (mm)Length (mm)Material
    ZENEX Implant System_Short (R-System)∅ 5.05/5.4/5.9/6.756.25Ti CP4 (ASTM F67)

    Tolerance of dimension shall be within ± 1% range.

    The subject devices are compatible with the following abutments made by Izenimplant Co., Ltd.

    K numberAbutment NameDiameter (∅)AngulationLength or Cuff(mm)Material + Surface Treatment
    K252585Cover Screw∅3.50˚P/H: 0.4/1.4/2.0Ti-6Al-4V ELI
    Healing Abutment∅4.2/5.2/6.2/7.2/8.0/9.00˚P/H: 3/4/5/6/7/9Ti-6Al-4V ELI
    Cemented Abutment∅4.0/5.0/6.0/7.00˚G/H: 1.8/2.8/3.8/4.8, PH: 5.5/7Ti-6Al-4V ELI + TiN Coating
    Angled Abutment∅4.0/5.0/6.0/7.015˚/25˚G/H: 1.8/2.8/3.8/4.8, P/H: 7Ti-6Al-4V ELI + TiN Coating
    Temporary Abutment∅4.00˚G/H: 0.8/2.8, P/H: 10Ti-6Al-4V ELI
    Ball Abutment∅3.50˚G/H: 0.8/1.8/2.8/3.8/4.8/5.8Ti-6Al-4V ELI
    Multi Abutment∅4.80˚/17˚/30˚G/H: 1.3/2.3/3.3/4.3Ti-6Al-4V ELI
    CCM Cast Abutment∅4.00˚G/H: 0.8/2.8, P/H: 10Co-Cr-Mo Alloy
    FreeMilling Abutment∅4.0/5.0/6.0/7.00˚G/H: 1.8/2.8/3.8/4.8, P/H: 9Ti-6Al-4V ELI + TiN Coating
    Abutment Screw∅2.10˚7.7Ti-6Al-4V ELI
    Multi Angled Abutment Screw∅2.050˚6.75Ti-6Al-4V ELI

    Fixture is provided sterile, and valid for 5 years.

    AI/ML Overview

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