BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Embrace Wetbond Low Fill

    DI: D701EMSWLFB2 · Model: EMSWLFB · PULPDENT CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Embrace Wetbond Low Fill
    Primary DI
    D701EMSWLFB2
    Version / Model
    EMSWLFB
    Company Name
    PULPDENT CORPORATION
    Labeler DUNS
    001006089
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-28
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    5fe0b13b-0088-428b-94eb-1d58372fd6b9

    Device Description

    Bulk Pack: 20 x 1.2 mL syringes Low Fill sealant, off-white shade + 100 applicator tips 7.9% filled

    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
    EBC Sealant, Pit And Fissure, And Conditioner

    GMDN Terms

    Code Name
    31780 Dental pit/fissure sealant

    Identifiers

    Type ID
    Primary D701EMSWLFB2