BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Implant 4.1*5

    DI: 07290112280664 · Model: EDI-4105 · DENTACK IMPLANTS LTD
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Implant 4.1*5
    Primary DI
    07290112280664
    Version / Model
    EDI-4105
    Company Name
    DENTACK IMPLANTS LTD
    Labeler DUNS
    514897185
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-27
    Public Version
    1
    Public Version Date
    2019-03-11
    Public Version Status
    New
    Public Device Record Key
    9e708f76-89e5-4ce8-a3fa-a60e707dc0f0

    Device Description

    Implant 4.1*5

    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
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    NHA Abutment, Implant, Dental, Endosseous
    DZE Implant, Endosseous, Root-Form

    GMDN Terms

    Code Name
    55849 Screw endosteal dental implant, two-piece

    Identifiers

    Type ID
    Primary 07290112280664

    Customer Contacts

    Phone
    +97297660379
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K180859 000