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

    VINTAGE HALO

    K Number: K973247 · Decision Oct 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    471
    Applicant Total
    59
    Review Days
    48

    Basic Information

    Device Name
    VINTAGE HALO
    K Number
    K973247
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SHOFU DENTAL CORP.
    Date Received
    August 29, 1997
    Decision Date
    October 16, 1997
    Product Code
    EIH
    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
    EIH Powder, Porcelain

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