BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Vertex-Dental BV

    DI: 08719425508559 · Model: NPENBAPI01000 · 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
    08719425508559
    Version / Model
    NPENBAPI01000
    Company Name
    Vertex-Dental B.V.
    Labeler DUNS
    406389056
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-16
    Public Version
    6
    Public Version Date
    2023-06-16
    Public Version Status
    Update
    Public Device Record Key
    4a90620a-b14a-4fe0-b245-7f8484111c91
    Distribution End Date
    2023-06-15

    Device Description

    E-Denture

    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
    No
    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
    EBI RESIN, DENTURE, RELINING, REPAIRING, REBASING

    GMDN Terms

    Code Name
    16730 Dental appliance fabrication material, resin

    Identifiers

    Type ID
    Primary 08719425508559

    Premarket Submissions

    Submission Number Supplement Number
    K162572 000