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

    DELTON ILLUMINATING PIT AND FISSURE SEALING

    K Number: K050959 · Decision May 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    130
    Applicant Total
    23
    Review Days
    23

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    Basic Information

    Device Name
    DELTON ILLUMINATING PIT AND FISSURE SEALING
    K Number
    K050959
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3765
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dentsply International
    Date Received
    April 18, 2005
    Decision Date
    May 11, 2005
    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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