BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DIAGNOdent pen 2190

    DI: EKAV100270000 · Model: 1.002.7000 · KaVo Dental GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DIAGNOdent pen 2190
    Primary DI
    EKAV100270000
    Version / Model
    1.002.7000
    Catalog Number
    2190
    Company Name
    KaVo Dental GmbH
    Labeler DUNS
    333710619
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-15
    Public Version
    1
    Public Version Date
    2022-04-25
    Public Version Status
    New
    Public Device Record Key
    40ac3ff6-1796-424b-9fb4-5cbbac5aa1b9

    Device Description

    This is a medical device.

    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 EKAV100270000

    Customer Contacts

    Phone
    +18885286872
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K060080 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    -10 – 55 Degrees Celsius