BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Suppra O-Cem Plus

    DI: 07899633828463 · Model: 4g · Dentscare Ltda
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Suppra O-Cem Plus
    Primary DI
    07899633828463
    Version / Model
    4g
    Catalog Number
    4000055571
    Company Name
    Dentscare Ltda
    Labeler DUNS
    898067533
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-11-01
    Public Version
    1
    Public Version Date
    2021-11-09
    Public Version Status
    New
    Public Device Record Key
    4973df65-ee12-40bd-8c18-6eeec754f1c3

    Device Description

    Suppra O-Cem Plus is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product removal from teeth, after removing brackets.

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EBF Material, Tooth Shade, Resin
    DYH Adhesive, Bracket And Tooth Conditioner, Resin

    GMDN Terms

    Code Name
    31750 Orthodontic bracket adhesive

    Identifiers

    Type ID
    Primary 07899633828463