BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OpaTray

    DI: D815OPATRAY1 · Model: OPATRAY · 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
    OpaTray
    Primary DI
    D815OPATRAY1
    Version / Model
    OPATRAY
    Catalog Number
    OPATRAY
    Company Name
    OPA DENTAL LLC
    Labeler DUNS
    053308044
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2018-10-21
    Public Version
    2
    Public Version Date
    2018-11-27
    Public Version Status
    Update
    Public Device Record Key
    683227c9-196f-41e6-a593-7a33cda887ce

    Device Description

    Light cure custom tray 2pcs

    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
    Yes
    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
    EBH Material, Impression Tray, Resin

    GMDN Terms

    Code Name
    58106 Dental impression tray material

    Identifiers

    Type ID
    Primary D815OPATRAY1
    Unit of Use D815OPATRAY01