BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OpaBite

    DI: D815OPABITE1 · Model: OPABITE · 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
    OpaBite
    Primary DI
    D815OPABITE1
    Version / Model
    OPABITE
    Catalog Number
    OPABITE
    Company Name
    OPA DENTAL LLC
    Labeler DUNS
    053308044
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2018-10-19
    Public Version
    3
    Public Version Date
    2019-11-04
    Public Version Status
    Update
    Public Device Record Key
    6f8ccfe7-3f8a-4332-9088-f2ecbbf14130

    Device Description

    Bite registration 50ml cartridge

    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
    ELW Material, Impression

    GMDN Terms

    Code Name
    35866 Silicone dental impression material

    Identifiers

    Type ID
    Primary D815OPABITE1
    Unit of Use D815OPABITE01