BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CamX Triton HD, Cam Spectra Proxi

    DI: E247J27001 · Model: J2700 · DÜRR DENTAL SE
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CamX Triton HD, Cam Spectra Proxi
    Primary DI
    E247J27001
    Version / Model
    J2700
    Company Name
    DÜRR DENTAL SE
    Labeler DUNS
    315563684
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-06
    Public Version
    1
    Public Version Date
    2018-08-06
    Public Version Status
    New
    Public Device Record Key
    1a15a231-0c1f-4c9c-9074-76bb34b0c61a

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NTK Caries Detector, Laser Light, Transmission

    GMDN Terms

    Code Name
    33995 Dental caries detector, optical induced fluorescence

    Identifiers

    Type ID
    Primary E247J27001

    Premarket Submissions

    Submission Number Supplement Number
    K172007 000