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

    PERIO PROTECT TRAY

    K Number: K031809 · Decision Jan 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    225

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    Basic Information

    Device Name
    PERIO PROTECT TRAY
    K Number
    K031809
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6870
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perio Protect, LLC
    Date Received
    June 12, 2003
    Decision Date
    January 23, 2004
    Product Code
    KMT
    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
    KMT Tray, Fluoride, Disposable

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