BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇷 Türkiye

    Nucleoss T6 Dental Implant System

    K Number: K192062 · Decision Aug 27, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    1
    Review Days
    392

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    Basic Information

    Device Name
    Nucleoss T6 Dental Implant System
    K Number
    K192062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST
    Date Received
    August 1, 2019
    Decision Date
    August 27, 2020
    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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