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

    PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN

    K Number: K071267 · Decision May 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    137
    Applicant Total
    7
    Review Days
    11

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    Basic Information

    Device Name
    PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN
    K Number
    K071267
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3260
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Novamin Technology, Inc.
    Date Received
    May 7, 2007
    Decision Date
    May 18, 2007
    Product Code
    LBH
    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
    LBH Varnish, Cavity

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    Other Clearances by Novamin Technology, Inc.

    K Number Device Name
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    K041371 BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN
    K040473 ORAVIVE TOOTH REVITALIZING PASTE
    K033295 BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN