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

    ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019

    K Number: K062886 · Decision Nov 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    130
    Applicant Total
    31
    Review Days
    41

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    Basic Information

    Device Name
    ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
    K Number
    K062886
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3765
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CAO Group, Inc.
    Date Received
    September 26, 2006
    Decision Date
    November 6, 2006
    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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