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

    FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS

    K Number: K890494 · Decision Mar 29, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    130
    Applicant Total
    5
    Review Days
    57

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    Basic Information

    Device Name
    FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS
    K Number
    K890494
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3765
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Macrochem Corp.
    Date Received
    January 31, 1989
    Decision Date
    March 29, 1989
    Product Code
    EBC
    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
    EBC Sealant, Pit And Fissure, And Conditioner

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