BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    DTX Studio™ Implant

    DI: 07332747158809 · Model: 3.3 · Nobel Biocare AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DTX Studio™ Implant
    Primary DI
    07332747158809
    Version / Model
    3.3
    Catalog Number
    300843
    Company Name
    Nobel Biocare AB
    Labeler DUNS
    353939929
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-07
    Public Version
    3
    Public Version Date
    2020-04-29
    Public Version Status
    Update
    Public Device Record Key
    fb30c779-c661-48a1-a1bd-c777936e8c0e
    Distribution End Date
    2019-03-05

    Device Description

    DTX Studio Implant 3.3 for Mac

    Device Characteristics

    Single Use
    No
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LLZ System, image processing, radiological

    GMDN Terms

    Code Name
    60883 Dental treatment application software

    Identifiers

    Type ID
    Primary 07332747158809

    Customer Contacts

    Phone
    +1(800)322-5001
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K163122 000