BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PROSOFT

    K Number: K121318 · Decision Jun 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    35

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    Basic Information

    Device Name
    PROSOFT
    K Number
    K121318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3560
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perma Laboratories
    Date Received
    May 2, 2012
    Decision Date
    June 6, 2012
    Product Code
    EBP
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    EBP Reliner, Denture, Over The Counter

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