BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BONA-BITE Air

    DI: 05206569000221 · Model: 50ml · DMP DENTAL INDUSTRY S.A.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    5
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BONA-BITE Air
    Primary DI
    05206569000221
    Version / Model
    50ml
    Company Name
    DMP DENTAL INDUSTRY S.A.
    Labeler DUNS
    728534814
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2021-03-30
    Public Version Status
    Update
    Public Device Record Key
    7e410d2f-e3c7-4aab-ad39-63f45b95845e

    Device Description

    Addition curing silicone bite registration material (Super Fast Set)

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ELW Material, Impression

    GMDN Terms

    Code Name
    35866 Silicone dental impression material

    Identifiers

    Type ID
    Package 05206569000047
    Primary 05206569000221
    Package 05206569000023
    Package 05206569001457
    Package 05206569002096

    Customer Contacts

    Phone
    +302299023041
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    10 – 25 Degrees Celsius