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

    BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN

    K Number: K041371 · Decision Aug 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    76
    Applicant Total
    7
    Review Days
    91

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    Basic Information

    Device Name
    BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN
    K Number
    K041371
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6030
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novamin Technology, Inc.
    Date Received
    May 24, 2004
    Decision Date
    August 23, 2004
    Product Code
    EJR
    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
    EJR Agent, Polishing, Abrasive, Oral Cavity

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