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

    HEMA-PRIMER

    K Number: K895750 · Decision Dec 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    133
    Registration Numbers
    133
    Same Product Code
    410
    Applicant Total
    8
    Review Days
    86

    Basic Information

    Device Name
    HEMA-PRIMER
    K Number
    K895750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    PARKELL
    Date Received
    September 26, 1989
    Decision Date
    December 21, 1989
    Product Code
    KLE
    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
    KLE Agent, Tooth Bonding, Resin

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