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

    SINGLES

    K Number: K930453 · Decision May 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    120

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    Basic Information

    Device Name
    SINGLES
    K Number
    K930453
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nexadental
    Date Received
    January 27, 1993
    Decision Date
    May 27, 1993
    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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