BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Envision Complete Bonding System (modified)

    DI: MEVKM1 · Model: EVKM · CHAMELEON DENTAL PRODUCTS, INC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Envision Complete Bonding System (modified)
    Primary DI
    MEVKM1
    Version / Model
    EVKM
    Company Name
    CHAMELEON DENTAL PRODUCTS, INC
    Labeler DUNS
    174145664
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-08
    Public Version
    1
    Public Version Date
    2018-12-10
    Public Version Status
    New
    Public Device Record Key
    419ff96a-c384-44d3-9fbe-2e31baa65f16

    Device Description

    Dental Bonding Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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

    GMDN Terms

    Code Name
    62477 Dental composite resin kit

    Identifiers

    Type ID
    Primary MEVKM1