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

    GLENROE ELASTIBITE STIMULATOR

    K Number: K924351 · Decision Jan 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    112
    Registration Numbers
    112
    Same Product Code
    11
    Applicant Total
    8
    Review Days
    496

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    Basic Information

    Device Name
    GLENROE ELASTIBITE STIMULATOR
    K Number
    K924351
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5525
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Glenroe Technologies
    Date Received
    August 28, 1992
    Decision Date
    January 6, 1994
    Product Code
    KMY
    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
    KMY Positioner, Tooth, Preformed

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