BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EMBRACE VARNISH - 5% SODIUM FLUORIDE WITH CXP™

    DI: D701FV502 · Model: FV50 · PULPDENT CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    EMBRACE VARNISH - 5% SODIUM FLUORIDE WITH CXP™
    Primary DI
    D701FV502
    Version / Model
    FV50
    Company Name
    PULPDENT CORPORATION
    Labeler DUNS
    001006089
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-21
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    f4bbfae9-8a4f-45c9-b3fb-fb0d731d115a

    Device Description

    50 x 0.4 mL Embrace Varnish unit dose with applicator brush

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LBH Varnish, Cavity

    GMDN Terms

    Code Name
    35698 Dental cavity varnish

    Identifiers

    Type ID
    Primary D701FV502

    Device Sizes

    Type Value Unit Text
    Total Volume 0.4 Milliliter