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510(k) Data Aggregation

    K Number
    K063321
    Device Name
    D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138
    Manufacturer
    NEKS TECHNOLOGIES, INC.
    Date Cleared
    2007-03-30

    (148 days)

    Product Code
    NBL
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEKS TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aid in diagnosis of dental pits and fissures and interproximal caries and aid in the detection of dental calculus.
    Device Description
    The D-Carie probe contains optical fibers that read the optical scattering characteristic of dental carie thru healthy enamel structure above (the marginal ridge over the vulnerable inteproximal area) and convert it into an electrical signal. From that signal a computer analysis identifies the dental caries. The device can be in either in a new handheld or a tabletop (original) format with the addition or not of the calculus detection feature of the Detectar.
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    K Number
    K043156
    Device Name
    D-CARIE, MODEL N121-M1
    Manufacturer
    NEKS TECHNOLOGIES, INC.
    Date Cleared
    2005-04-28

    (164 days)

    Product Code
    NBL
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEKS TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    D-Carie is indicated for aiding in the diagnosis of dental carries
    Device Description
    Similar to the Diagnodent the D-CARIE is indicated for use in aiding in the diagnosis of dental caries. The D-CARIE probe is similar in intended use, size, and shape to a Diagnodent probe tip. Identical to the technology in the Detectar the D-CARIE probe contains an optical fiber that reads the optical signature of suspicious areas and converts it into an electrical signal. From that electrical signal a computer analysis identifies areas that need further examination.
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    K Number
    K023367
    Device Name
    DETECTAR, MODEL N123-MI
    Manufacturer
    NEKS TECHNOLOGIES
    Date Cleared
    2003-06-25

    (260 days)

    Product Code
    EJB, NBL
    Regulation Number
    872.4565
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEKS TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DETECTAR is indicated for use in the detection of subgingival dental calculus. DETECTAR is indicated for the detection of subgingival dental calculus
    Device Description
    The DETECTAR probe is similar in intended use, size, and shape to a manual periodontal probe. The DETECTAR probe contains an optical fiber that reads the optical signature of dental calculus and converts it into an electrical signal. From that electrical signal a computer analysis identifies the dental calculus.
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