BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LightForce Orthodontic System

    DI: 00860270000953 · Model: 08.23.18.1.PCA.TBW.WJ · LIGHTFORCE ORTHODONTICS, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    LightForce Orthodontic System
    Primary DI
    00860270000953
    Version / Model
    08.23.18.1.PCA.TBW.WJ
    Company Name
    LIGHTFORCE ORTHODONTICS, INC.
    Labeler DUNS
    096883072
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-23
    Public Version
    5
    Public Version Date
    2025-07-02
    Public Version Status
    Update
    Public Device Record Key
    e346da1a-00de-4ad1-b9ec-e25949589b0a

    Device Description

    Patient Specific Orthodontic Brackets with Indirect Bonding Jigs and Software Material: Polycrystalline Alumina

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    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

    GMDN Terms

    Code Name
    58937 Orthodontic bracket, ceramic

    Identifiers

    Type ID
    Primary 00860270000953