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    FDA UDI In Commercial Distribution 🇺🇸 United States

    PriZma 3D Bio Ortho IBT (500 g)

    DI: 07898561547347 · Model: PriZma 3D Bio Ortho · Maquira Industria de Produtos Odontologicos S/A
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PriZma 3D Bio Ortho IBT (500 g)
    Primary DI
    07898561547347
    Version / Model
    PriZma 3D Bio Ortho
    Catalog Number
    80483740004
    Company Name
    Maquira Industria de Produtos Odontologicos S/A
    Labeler DUNS
    679266866
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-09-05
    Public Version
    1
    Public Version Date
    2025-09-15
    Public Version Status
    New
    Public Device Record Key
    32dc8d5b-d137-4abf-b487-959efe09e8d2

    Device Description

    PRIZMA 3D BIO ORTHO IBT is a UVA/UVB light cured resin exclusively for use in 3D printers. Indicated for manufacture of indirect bonding guides for orthodontic brackets.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    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
    EJF Bracket, Metal, Orthodontic

    GMDN Terms

    Code Name
    16730 Dental appliance fabrication material, resin

    Identifiers

    Type ID
    Primary 07898561547347