BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dental LT Clear V2

    DI: 00850061175076 · Model: FLDLCL02 · FORMLABS OHIO INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dental LT Clear V2
    Primary DI
    00850061175076
    Version / Model
    FLDLCL02
    Company Name
    FORMLABS OHIO INC.
    Labeler DUNS
    106744280
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-24
    Public Version
    1
    Public Version Date
    2024-05-02
    Public Version Status
    New
    Public Device Record Key
    d46ab4f3-8b75-4210-ace8-f090f12e40ba

    Device Description

    Dental LT Clear V2 for cartridge V2

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KMY Positioner, Tooth, Preformed
    DYT Maintainer, Space Preformed, Orthodontic
    MQC Mouthguard, Prescription

    GMDN Terms

    Code Name
    16730 Dental appliance fabrication material, resin

    Identifiers

    Type ID
    Primary 00850061175076