BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    All Smiles Safebond

    DI: 07899633830893 · Model: 5mL · Dentscare Ltda
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    All Smiles Safebond
    Primary DI
    07899633830893
    Version / Model
    5mL
    Catalog Number
    4000055911
    Company Name
    Dentscare Ltda
    Labeler DUNS
    898067533
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-01
    Public Version
    2
    Public Version Date
    2024-02-16
    Public Version Status
    Update
    Public Device Record Key
    aca4595c-f71a-4e76-9a28-32f6887f739f

    Device Description

    All Smiles Safebond is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KLE Agent, Tooth Bonding, Resin

    GMDN Terms

    Code Name
    34782 Dentine bonding agent/set

    Identifiers

    Type ID
    Primary 07899633830893