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

    TRIMIRA IDENTAFI 3000

    K Number: K090135 · Decision Feb 17, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    TRIMIRA IDENTAFI 3000
    K Number
    K090135
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.6350
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Remicalm, LLC
    Date Received
    January 21, 2009
    Decision Date
    February 17, 2009
    Product Code
    NXV
    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
    NXV Diagnostic Light, Soft Tissue Detector

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    Other Clearances by Remicalm, LLC

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