BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ZERAMEX® XT Implant Ø3.5x10mm SB (incl. Healing Cap)

    DI: 07640161394018 · Model: XT15510 · Dentalpoint AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ZERAMEX® XT Implant Ø3.5x10mm SB (incl. Healing Cap)
    Primary DI
    07640161394018
    Version / Model
    XT15510
    Company Name
    Dentalpoint AG
    Labeler DUNS
    483229493
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-13
    Public Version
    2
    Public Version Date
    2023-02-06
    Public Version Status
    Update
    Public Device Record Key
    c33b152c-344e-400c-8a48-fa6df653dbd6

    Device Description

    Dental Implant

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DZE Implant, Endosseous, Root-Form

    GMDN Terms

    Code Name
    55847 Dental implant system

    Identifiers

    Type ID
    Primary 07640161394018

    Premarket Submissions

    Submission Number Supplement Number
    K163043 000
    K180184 000