BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GLENROE GLOW IN DARK ELASTOMERIC LIGATURES

    K Number: K973495 · Decision Dec 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    76

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    Basic Information

    Device Name
    GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
    K Number
    K973495
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Glenroe
    Date Received
    September 16, 1997
    Decision Date
    December 1, 1997
    Product Code
    ECI
    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
    ECI Band, Elastic, Orthodontic

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    Other Clearances by Glenroe

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