BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Ossix Breeze

    Reg #: 3027602316 · FEI: 3027602316 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Datum Dental Ltd.
    Registration Number
    3027602316
    FEI Number
    3027602316
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    38 Hayarkon St.
    City
    Yavne Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K212509

    Owner / Operator

    Firm Name
    DENTSPLY SIRONA INC
    Operator Number
    2511302
    Address
    221 WEST PHILADELPHIA ST., SUITE 60W
    City
    York
    State
    PA
    Postal Code
    17401
    Country
    US

    Products

    Device Name Product Code
    Barrier, Animal Source, Intraoral NPL

    Proprietary Names

    Ossix Breeze Ossix Agile

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device