BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    MIS Internal Hex Dental Implant System

    K Number: K180282 · Decision Jun 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    333
    Registration Numbers
    333
    Same Product Code
    1516
    Applicant Total
    4
    Review Days
    142

    Basic Information

    Device Name
    MIS Internal Hex Dental Implant System
    K Number
    K180282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MIS Implants Technologies Ltd.
    Date Received
    January 31, 2018
    Decision Date
    June 22, 2018
    Product Code
    DZE
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DZE Implant, Endosseous, Root-Form

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