BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NBB External Hex

    DI: D985HE359050 · Model: 3.5 Lock-Attach Abutment · FUSION DENTAL IMPLANTS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NBB External Hex
    Primary DI
    D985HE359050
    Version / Model
    3.5 Lock-Attach Abutment
    Catalog Number
    HE35905
    Company Name
    FUSION DENTAL IMPLANTS LLC
    Labeler DUNS
    081135800
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-04-25
    Public Version
    2
    Public Version Date
    2018-07-06
    Public Version Status
    New
    Public Device Record Key
    c2d8b64b-d609-40b0-bbe7-f238351bd89d

    Device Description

    Lock-Attach Dental Implant Abutment

    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
    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

    GMDN Terms

    Code Name
    55844 Basket endosteal dental implant, two-piece

    Identifiers

    Type ID
    Primary D985HE359050

    Premarket Submissions

    Submission Number Supplement Number
    K915375 000