BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    APOZA

    DI: 04719883750228 · Model: BT Cool Plus · APOZA ENTERPRISE CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    APOZA
    Primary DI
    04719883750228
    Version / Model
    BT Cool Plus
    Company Name
    APOZA ENTERPRISE CO., LTD.
    Labeler DUNS
    656816337
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-26
    Public Version
    1
    Public Version Date
    2023-07-04
    Public Version Status
    New
    Public Device Record Key
    249bbcd8-0f74-494c-87d7-57833099ff6c

    Device Description

    This unit is designed for in-office tooth bleaching. This unit must be operated by licensed dental professionals only.

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EEG Heat Source For Bleaching Teeth

    GMDN Terms

    Code Name
    31806 Tooth-bleaching acceleration unit

    Identifiers

    Type ID
    Primary 04719883750228