BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SHINING 3D® Intraoral Scanner

    DI: 06970163080017 · Model: Aoralscan 2 · Shining 3D Tech Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SHINING 3D® Intraoral Scanner
    Primary DI
    06970163080017
    Version / Model
    Aoralscan 2
    Company Name
    Shining 3D Tech Co., Ltd.
    Labeler DUNS
    529835314
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-16
    Public Version
    1
    Public Version Date
    2020-09-24
    Public Version Status
    New
    Public Device Record Key
    d82feeeb-9e6b-459a-b147-b3f19b808078

    Device Description

    The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    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
    63669 Intraoral optical scanning system

    Identifiers

    Type ID
    Primary 06970163080017