BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DenteShield™ Pit & Fissure Sealant PLUS

    DI: 00851951008115 · Model: SBD-650-3 · SELENBIO DENTAL, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DenteShield™ Pit & Fissure Sealant PLUS
    Primary DI
    00851951008115
    Version / Model
    SBD-650-3
    Company Name
    SELENBIO DENTAL, INC.
    Labeler DUNS
    080965107
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-07
    Public Version
    1
    Public Version Date
    2019-08-15
    Public Version Status
    New
    Public Device Record Key
    9cad76b8-81d1-4377-a3b5-987754e8622e

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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

    GMDN Terms

    Code Name
    62477 Dental composite resin kit

    Identifiers

    Type ID
    Primary 00851951008115