BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ambar Universal APS

    DI: 07899633815944 · Model: 5mL · Dentscare Ltda
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ambar Universal APS
    Primary DI
    07899633815944
    Version / Model
    5mL
    Catalog Number
    4000019361
    Company Name
    Dentscare Ltda
    Labeler DUNS
    898067533
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-31
    Public Version
    4
    Public Version Date
    2024-02-16
    Public Version Status
    Update
    Public Device Record Key
    b7ebeac1-f381-44df-bc6e-7d62f8c671b3

    Device Description

    Ambar Universal APS 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 07899633815944