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

    OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT

    K Number: K891140 · Decision May 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    130
    Applicant Total
    20
    Review Days
    59

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    Basic Information

    Device Name
    OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT
    K Number
    K891140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3765
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Coe Laboratories, Inc.
    Date Received
    March 3, 1989
    Decision Date
    May 1, 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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