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

    PREFORMED TOOTH POSITIONER

    K Number: K780619 · Decision Jun 28, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    112
    Registration Numbers
    112
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    76

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    Basic Information

    Device Name
    PREFORMED TOOTH POSITIONER
    K Number
    K780619
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5525
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Tp Laboratories, Inc.
    Date Received
    April 13, 1978
    Decision Date
    June 28, 1978
    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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