BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Disposable Impression Bite Tray

    DI: 08800017902098 · Model: Quadrant · DXM CO., LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Disposable Impression Bite Tray
    Primary DI
    08800017902098
    Version / Model
    Quadrant
    Catalog Number
    [BT-3000]
    Company Name
    DXM CO., LTD
    Labeler DUNS
    688797315
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-11
    Public Version
    1
    Public Version Date
    2024-06-19
    Public Version Status
    New
    Public Device Record Key
    db26bd7c-bd2c-4db5-b4e0-4e5dc9c15c45

    Device Description

    Disposable Impression Bite Trays with stainless-steel edge frames used to make an impression of a patient's teeth or alveolar process (bony tooth sockets). Rigid construction with stainless-steel edge frames provides less distortion and firmly holds the impression. DIBT is specifically made thinner and longer for higher accuracy of impressions.

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    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
    16350 Dental impression tray, single-use

    Identifiers

    Type ID
    Primary 08800017902098