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

    HERCULITE ULTRA

    K Number: K082671 · Decision Dec 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    15
    Review Days
    87

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    Basic Information

    Device Name
    HERCULITE ULTRA
    K Number
    K082671
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sybron Dental Specialties
    Date Received
    September 15, 2008
    Decision Date
    December 11, 2008
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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