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

    DTI-1 SLA IMPLANT SYSTEM

    K Number: K170776 · Decision Apr 10, 2018
    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
    DTI-1 SLA IMPLANT SYSTEM
    K Number
    K170776
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi
    Date Received
    March 14, 2017
    Decision Date
    April 10, 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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