BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vertex-Dental BV

    DI: 08719425509280 · Model: NDOICL01000_1 · Vertex-Dental B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vertex-Dental BV
    Primary DI
    08719425509280
    Version / Model
    NDOICL01000_1
    Company Name
    Vertex-Dental B.V.
    Labeler DUNS
    406389056
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-03
    Public Version
    1
    Public Version Date
    2023-08-11
    Public Version Status
    New
    Public Device Record Key
    115ef463-b76b-4050-b282-49dd954aa783

    Device Description

    For the manufacturing of 3D printed Indirect bonding trays

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EBH MATERIAL, IMPRESSION TRAY, RESIN

    GMDN Terms

    Code Name
    58106 Dental impression tray material

    Identifiers

    Type ID
    Primary 08719425509280