BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Unica Proximal

    DI: E29969130 · Model: 6913 · Polydentia SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

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    Basic Information

    Brand Name
    Unica Proximal
    Primary DI
    E29969130
    Version / Model
    6913
    Catalog Number
    6913
    Company Name
    Polydentia SA
    Labeler DUNS
    481461598
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2025-04-29
    Public Version
    1
    Public Version Date
    2025-05-07
    Public Version Status
    New
    Public Device Record Key
    791ba0e9-88ab-4692-97fb-d24b6c3dc6da

    Device Description

    anterior matrices

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DZN Instruments, Dental Hand

    GMDN Terms

    Code Name
    38786 Dental matrix band, single-use

    Identifiers

    Type ID
    Unit of Use E29969139
    Primary E29969130