BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Circle One

    DI: 03760434300004 · Model: V.1.X.X · CIRCLE ANATOSCOPE INTUITIVE DESIGN
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Circle One
    Primary DI
    03760434300004
    Version / Model
    V.1.X.X
    Company Name
    CIRCLE ANATOSCOPE INTUITIVE DESIGN
    Labeler DUNS
    268404822
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-28
    Public Version
    2
    Public Version Date
    2025-10-06
    Public Version Status
    Update
    Public Device Record Key
    be384216-267d-413e-af20-273e139ebda6

    Device Description

    Circle ONE Design is a software device intended to support the design of the following dental prostheses: full crowns, partial crowns (onlay, inlay, overlay), veneers. It allows the import of 3D intraoral scan data and provides automated prosthetic design proposals that can be reviewed, adjusted and exported for manufacturing.

    Device Characteristics

    Single Use
    No
    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
    Yes
    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
    No

    Product Codes

    Code Name
    NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

    GMDN Terms

    Code Name
    38597 Dental milling system, CAD/CAM, chairside

    Identifiers

    Type ID
    Primary 03760434300004