BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ITL Dental

    DI: 00817686026619 · Model: HCM-3730S · EMERY ENTERPRISES INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ITL Dental
    Primary DI
    00817686026619
    Version / Model
    HCM-3730S
    Company Name
    EMERY ENTERPRISES INC
    Labeler DUNS
    836292029
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-18
    Public Version
    1
    Public Version Date
    2021-09-27
    Public Version Status
    New
    Public Device Record Key
    ce0eb6bc-55d0-4957-b909-3d25511c0712

    Device Description

    HCM-3730S HEALING CAP, 3.5P, US, 3mmH Cervical

    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
    Yes
    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
    DZE Implant, Endosseous, Root-Form

    GMDN Terms

    Code Name
    55849 Screw endosteal dental implant, two-piece

    Identifiers

    Type ID
    Primary 00817686026619