BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ultrasonic Tip 0.3mm (BUST-03)

    DI: 08800027200108 · Model: BUST-03 · BioMTA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ultrasonic Tip 0.3mm (BUST-03)
    Primary DI
    08800027200108
    Version / Model
    BUST-03
    Company Name
    BioMTA
    Labeler DUNS
    688731057
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-01
    Public Version
    3
    Public Version Date
    2019-02-21
    Public Version Status
    Update
    Public Device Record Key
    abd55f48-d0e6-4bd5-9490-c2e951d4d22d

    Device Description

    Used to remove dental calculus. Also, it is used to remove foreign substances in the middle to apical area of the root canal.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Liquid Chemical", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    DZP Instrument, Diamond, Dental

    GMDN Terms

    Code Name
    46035 Ultrasonic dental scaling/debridement system handpiece tip, endodontic

    Identifiers

    Type ID
    Primary 08800027200108