BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Helioseal F

    DI: DVIV543793AN1 · Model: 543793AN · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Helioseal F
    Primary DI
    DVIV543793AN1
    Version / Model
    543793AN
    Catalog Number
    543793AN
    Company Name
    IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    Labeler DUNS
    448015938
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2016-12-12
    Public Version
    3
    Public Version Date
    2022-01-27
    Public Version Status
    Update
    Public Device Record Key
    146d4025-c414-41fb-8a53-65e9d7e32c7c
    Distribution End Date
    2022-01-26

    Device Description

    Sealants

    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
    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
    35870 Dental composite resin

    Identifiers

    Type ID
    Primary DVIV543793AN1
    Unit of Use DVIV543793AN0