BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OCTYLDENT

    K Number: K884652 · Decision May 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    2
    Review Days
    198

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    Basic Information

    Device Name
    OCTYLDENT
    K Number
    K884652
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Crx Medical, Inc.
    Date Received
    November 7, 1988
    Decision Date
    May 24, 1989
    Product Code
    EMA
    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
    EMA Cement, Dental

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    Other Clearances by Crx Medical, Inc.

    K Number Device Name
    K902078 ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY.