BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MK-dent

    DI: E490QC6116K1 · Model: ACCESSORIES · MK-Dent GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    MK-dent
    Primary DI
    E490QC6116K1
    Version / Model
    ACCESSORIES
    Catalog Number
    QC6116K
    Company Name
    MK-Dent GmbH
    Labeler DUNS
    343618943
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-14
    Public Version
    1
    Public Version Date
    2024-10-22
    Public Version Status
    New
    Public Device Record Key
    6d2027a7-1234-43ac-9d6f-95750a4ab5ed

    Device Description

    Coupling

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EFB Handpiece, Air-Powered, Dental

    GMDN Terms

    Code Name
    45121 Pneumatic dental handpiece coupler

    Identifiers

    Type ID
    Primary E490QC6116K1

    Premarket Submissions

    Submission Number Supplement Number
    K032234 000