BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Denture

    DI: 08936214220038 · Model: 003 · ACESO DENTAL LABORATORY COMPANY LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Denture
    Primary DI
    08936214220038
    Version / Model
    003
    Company Name
    ACESO DENTAL LABORATORY COMPANY LIMITED
    Labeler DUNS
    673251143
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-03
    Public Version
    1
    Public Version Date
    2022-10-11
    Public Version Status
    New
    Public Device Record Key
    631fd7ff-23e5-41c6-9beb-df540451ed4b

    Device Description

    Full dentures are manufactured as finished products from denture resins.

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    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
    NSL Dentures, Full

    GMDN Terms

    Code Name
    38588 Complete upper denture
    38589 Complete lower denture

    Identifiers

    Type ID
    Primary 08936214220038