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

    NITE-GUIDE

    K Number: K931615 · Decision Apr 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    112
    Registration Numbers
    112
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    743

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    Basic Information

    Device Name
    NITE-GUIDE
    K Number
    K931615
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5525
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ORTHO-TAIN, Inc.
    Date Received
    April 1, 1993
    Decision Date
    April 14, 1995
    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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    Other Clearances by ORTHO-TAIN, Inc.

    K Number Device Name
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