BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Dentbird Solution

    DI: 08809953520007 · Model: Dentbird Crown V.2.x.x · IMAGOWORKS Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Dentbird Solution
    Primary DI
    08809953520007
    Version / Model
    Dentbird Crown V.2.x.x
    Company Name
    IMAGOWORKS Inc.
    Labeler DUNS
    963215271
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-04
    Public Version
    2
    Public Version Date
    2023-12-06
    Public Version Status
    Update
    Public Device Record Key
    78993b31-963a-45ab-9b1e-76844ac1c2f1
    Distribution End Date
    2023-10-29

    Device Description

    Dentbird Crown is a software intended to support dental crown design using 3D data from a patient's oral scan image. It receives oral scan data as input and recommends the tooth number, margin lines, and initial values for a dental crown design using a deep learning model and CAD algorithm. Additionally, users can directly design the dental crown. The software can accept and export 3D intraoral scan data in a universal file format (.stl, .ply, .obj).

    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
    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 08809953520007