BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Cavity Cleanser

    DI: D757B2807A1 · Model: B-2807A · BISCO INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cavity Cleanser
    Primary DI
    D757B2807A1
    Version / Model
    B-2807A
    Catalog Number
    B-2807A
    Company Name
    BISCO INC.
    Labeler DUNS
    053529939
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-12
    Public Version
    7
    Public Version Date
    2022-11-18
    Public Version Status
    Update
    Public Device Record Key
    61779e41-9f12-4ac0-88e6-f857bfdae8e1
    Distribution End Date
    2022-11-17

    Device Description

    Cavity Cleanser 7ml Bottle Pkg

    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
    EBF MATERIAL, TOOTH SHADE, RESIN

    GMDN Terms

    Code Name
    34524 Dental tooth-cleaning solution

    Identifiers

    Type ID
    Primary D757B2807A1

    Customer Contacts

    Phone
    +1(847)534-6000
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K915668 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    20 – 25 Degrees Celsius