BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TRIOCLEAR System

    DI: 06972677870139 · Model: 013 · Modern Dental Laboratory (DG) Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TRIOCLEAR System
    Primary DI
    06972677870139
    Version / Model
    013
    Company Name
    Modern Dental Laboratory (DG) Co., Ltd.
    Labeler DUNS
    551746187
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-08
    Public Version
    2
    Public Version Date
    2023-05-19
    Public Version Status
    Update
    Public Device Record Key
    a4d8ef4d-31a1-45da-a181-d641c341ce5b

    Device Description

    The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NXC Aligner, Sequential

    GMDN Terms

    Code Name
    44738 Orthodontic progressive aligner

    Identifiers

    Type ID
    Primary 06972677870139