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    K Number
    K252585

    Validate with FDA (Live)

    Device Name
    ZENEX Implant System_R-System
    Manufacturer
    Izenimplant Co., Ltd.
    Date Cleared
    2026-01-08

    (146 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K140091,K181138,K203240,K210826,K231557,K211090
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K140091, K181138, K203240, K210826, K231557

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

    ZENEX Implant System 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.

    Device Description

    ZENEX Implant System_R-System is a thread type implant made of pure titanium according to ASTM F 67 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).

    There are 2 types of fixtures, and the dimensions are as following:

    NameFixture TypeDiameter (mm)Length (mm)Material
    ZENEX MULTI Fixture∅ 3.85/4.25/4.6/5.05/5.4/5.9/6.757mm/8.5mm/10mm/11.5mm/13mm/15mmTi CP4 (ASTM F67)
    ZENEX PLUS Fixture∅ 3.85/4.25/4.6/5.05/5.47mm/8.5mm/10mm/11.5mm/13mm/15mm

    Tolerance of dimension shall be within ± 1% range.

    The Abutments are below:

    Abutment NameDiameter (∅)AngulationLength or Cuff(mm)Material + Surface Treatment
    Cover Screw∅3.50˚P/H: 0.4/1.4/2.0Ti-6Al-4V ELI
    Healing Abutment∅4.2/5.2/6.2/7.20˚P/H: 3/4/5/6/7/9Ti-6Al-4V ELI
    ∅8.0P/H: 3/4/5/6/7
    ∅9.0P/H: 3/4/5
    Cemented Abutment∅4.0/5.0/6.0/7.00˚G/H: 1.8/2.8/3.8/4.8 P/H: 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∅4.00˚G/H: 1.8/2.8/3.8 P/H: 9Ti-6Al-4V ELI + TiN Coating
    ∅5.0/6.0/7.0G/H: 1.8/2.8/3.8 P/H: 8
    Abutment Screw∅2.05/2.10˚6.75/7.7Ti-6Al-4V ELI

    Fixture, Cover Screw, Healing Abutment is provided sterile, and valid for 5 years.
    Other abutments are provided non-sterile and sterilized by end users.

    AI/ML Overview

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