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

    PCXX VARNISH

    K Number: K113146 · Decision Jan 23, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    137
    Applicant Total
    1
    Review Days
    91

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    Basic Information

    Device Name
    PCXX VARNISH
    K Number
    K113146
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3260
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ross Healthcare, Inc.
    Date Received
    October 24, 2011
    Decision Date
    January 23, 2012
    Product Code
    LBH
    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
    LBH Varnish, Cavity

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