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

    OPTIONS FOR STAR DENTAL OPUS I

    K Number: K761264 · Decision Dec 23, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    17
    Applicant Total
    10
    Review Days
    7

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    Basic Information

    Device Name
    OPTIONS FOR STAR DENTAL OPUS I
    K Number
    K761264
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Syntex Corp.
    Date Received
    December 16, 1976
    Decision Date
    December 23, 1976
    Product Code
    DYN
    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
    DYN Mouthpiece, Saliva Ejector

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