BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ortho Bite

    DI: 07899633815982 · Model: 4g · Dentscare Ltda
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ortho Bite
    Primary DI
    07899633815982
    Version / Model
    4g
    Catalog Number
    4000019365
    Company Name
    Dentscare Ltda
    Labeler DUNS
    898067533
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-27
    Public Version
    1
    Public Version Date
    2022-05-05
    Public Version Status
    New
    Public Device Record Key
    2db04e89-5d71-44ad-9ac2-15577334f34a

    Device Description

    Ortho Bite is a light-curing self-adhesive composite with self-levelling characteristics and surface hardness. The product is indicated for cementing orthodontic bands and is also suitable for temporary dental disocclusion during orthodontic treatment. The product is colored in order to facilitate its identification during application and removal.

    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 07899633815982