BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Nic Tone, MDC Dental

    DI: 07506338300322 · Model: Bisacryl · MDC DENTAL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Nic Tone, MDC Dental
    Primary DI
    07506338300322
    Version / Model
    Bisacryl
    Company Name
    MDC DENTAL
    Labeler DUNS
    811180298
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-14
    Public Version
    2
    Public Version Date
    2022-09-23
    Public Version Status
    Update
    Public Device Record Key
    9a11266b-0b4a-4cf8-b23d-55efa554e1ca

    Device Description

    Acrylic Temporary Resin for dental use, Tone BLEACH. Content: 1 Cartridge, with 76 g + 10 mixing tips.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    EBG Crown And Bridge, Temporary, Resin

    GMDN Terms

    Code Name
    45236 Temporary dental crown/bridge resin

    Identifiers

    Type ID
    Primary 07506338300322

    Customer Contacts

    Phone
    +523338330333
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K991577 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    23 – 25 Degrees Celsius