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

    NEXADENT (DENTAL CEMENT)

    K Number: K870209 · Decision Feb 19, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    NEXADENT (DENTAL CEMENT)
    K Number
    K870209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Bionexus, Inc.
    Date Received
    January 20, 1987
    Decision Date
    February 19, 1987
    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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