BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    TRUST

    K Number: K221107 · Decision Jul 18, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    459

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    Basic Information

    Device Name
    TRUST
    K Number
    K221107
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rgorithm Korea
    Date Received
    April 15, 2022
    Decision Date
    July 18, 2023
    Product Code
    PNP
    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
    PNP Dental Abutment Design Software For Dental Laboratory

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