BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Evolve by 3D Dental

    DI: 00817169028796 · Model: EVALUL2 · 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Evolve by 3D Dental
    Primary DI
    00817169028796
    Version / Model
    EVALUL2
    Catalog Number
    EVALUL2
    Company Name
    3D DENTAL DESIGNS AND DEVELOPMENT, LLC
    Labeler DUNS
    080194935
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-28
    Public Version
    2
    Public Version Date
    2023-11-17
    Public Version Status
    Update
    Public Device Record Key
    616f61c1-8e9f-4f2d-968a-55fce9a6e302

    Device Description

    Evolve Stainless Steel Primary Anterior Lateral Upper Left #2 Crowns Box

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    ELZ Crown, Preformed

    GMDN Terms

    Code Name
    34979 Rigid optical culdoscope

    Identifiers

    Type ID
    Primary 00817169028796