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

    OPUS I OPTION - FIBER OPTIC L SYSTEM

    K Number: K761331 · Decision Jan 3, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    17
    Applicant Total
    10
    Review Days
    7

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    Basic Information

    Device Name
    OPUS I OPTION - FIBER OPTIC L SYSTEM
    K Number
    K761331
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4620
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Syntex Corp.
    Date Received
    December 27, 1976
    Decision Date
    January 3, 1977
    Product Code
    EAY
    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
    EAY Light, Fiber Optic, Dental

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