BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DENTAMERICA

    DI: 00858466005097 · Model: 416 · DENTAMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DENTAMERICA
    Primary DI
    00858466005097
    Version / Model
    416
    Company Name
    DENTAMERICA, INC.
    Labeler DUNS
    174436360
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-21
    Public Version
    1
    Public Version Date
    2026-04-29
    Public Version Status
    New
    Public Device Record Key
    bffe5d40-c044-4f5f-b420-a15a63df899d

    Device Description

    SCREW PROPHYLAXIS POLISHING BRUSHES

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EHK Cup, Prophylaxis

    GMDN Terms

    Code Name
    64015 Dental-professional prophylaxis brush, single-use

    Identifiers

    Type ID
    Primary 00858466005097