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

    BRITESMILE BARRIER MATERIAL

    K Number: K010935 · Decision Sep 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    110
    Registration Numbers
    110
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    161

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    Basic Information

    Device Name
    BRITESMILE BARRIER MATERIAL
    K Number
    K010935
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6300
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Britesmile, Inc.
    Date Received
    March 28, 2001
    Decision Date
    September 5, 2001
    Product Code
    EIE
    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
    EIE Dam, Rubber

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