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

    RELAX-O-GUARD

    K Number: K925064 · Decision Sep 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    112
    Registration Numbers
    112
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    342

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    Basic Information

    Device Name
    RELAX-O-GUARD
    K Number
    K925064
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5525
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Aquatemp Service Co., Inc.
    Date Received
    October 6, 1992
    Decision Date
    September 13, 1993
    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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