BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DX-Condenser

    DI: 08800017900223 · Model: Set · DXM CO., LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DX-Condenser
    Primary DI
    08800017900223
    Version / Model
    Set
    Company Name
    DXM CO., LTD
    Labeler DUNS
    688797315
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-07-15
    Public Version
    1
    Public Version Date
    2024-07-23
    Public Version Status
    New
    Public Device Record Key
    ad296b70-2e2b-4cf7-a872-3fa712a6b991

    Device Description

    Nickel titanium and a stainless-steel end. Can be used in any common obturation technique, including warm and cold condensation. Excellent tactile sense and durability.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EKR Plugger, Root Canal, Endodontic

    GMDN Terms

    Code Name
    41876 Endodontic plugger

    Identifiers

    Type ID
    Primary 08800017900223
    Package 08800017901800