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

    PASTE, PRO CARE PROPHYLAXIS

    K Number: K782104 · Decision Jan 3, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    41
    Applicant Total
    16
    Review Days
    15

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    Basic Information

    Device Name
    PASTE, PRO CARE PROPHYLAXIS
    K Number
    K782104
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Young Dental Manufacturing Co. 1, LLC
    Date Received
    December 19, 1978
    Decision Date
    January 3, 1979
    Product Code
    FZE
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FZE Prosthesis, Nose, Internal

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