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

    TROLL-BITE

    K Number: K853451 · Decision Jan 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    158

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    Basic Information

    Device Name
    TROLL-BITE
    K Number
    K853451
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.1905
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Trollplast, Inc.
    Date Received
    August 16, 1985
    Decision Date
    January 21, 1986
    Product Code
    EGZ
    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
    EGZ Holder, Film, X-Ray

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