BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Orea Plus

    DI: D815OREAPL8540C41 · Model: OREAPL8540C4 · OPA DENTAL LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

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    Basic Information

    Brand Name
    Orea Plus
    Primary DI
    D815OREAPL8540C41
    Version / Model
    OREAPL8540C4
    Catalog Number
    OREAPL8540C4
    Company Name
    OPA DENTAL LLC
    Labeler DUNS
    053308044
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2019-02-15
    Public Version
    1
    Public Version Date
    2019-03-11
    Public Version Status
    New
    Public Device Record Key
    6792439e-c38a-4d36-8af5-8306496e794e

    Device Description

    Orea Plus dental zirconia

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EIH Powder, Porcelain

    GMDN Terms

    Code Name
    16187 Dental appliance fabrication material, ceramic

    Identifiers

    Type ID
    Primary D815OREAPL8540C41
    Unit of Use D815OREAPL8540C401