BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SHINING 3D®

    DI: 06975338700134 · Model: CB11-A1 · Hangzhou SHINING3D Dental Technology Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SHINING 3D®
    Primary DI
    06975338700134
    Version / Model
    CB11-A1
    Company Name
    Hangzhou SHINING3D Dental Technology Co., Ltd.
    Labeler DUNS
    406871432
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-10
    Public Version
    1
    Public Version Date
    2023-07-18
    Public Version Status
    New
    Public Device Record Key
    eb3989f5-6e29-48d1-b223-46b7e9cacb97

    Device Description

    The product is used for 3D printing denture teeth.

    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
    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
    Yes
    Sterilization Methods
    Liquid Chemical

    Product Codes

    Code Name
    PZY Additively Manufactured, Preformed, Resin Denture Tooth

    GMDN Terms

    Code Name
    16730 Dental appliance fabrication material, resin

    Identifiers

    Type ID
    Primary 06975338700134