BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    SendoCem MTA

    Reg #: 8030938 · FEI: 3004586882 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DIRECTA AB
    Registration Number
    8030938
    FEI Number
    3004586882
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PO BOX 723, FINVIDS VAG 8
    City
    UPPLANDS VAESBY Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K112078

    Owner / Operator

    Firm Name
    DIRECTA AB
    Operator Number
    9004750
    Address
    P.O.BOX 723, FINVIDS VAG 8
    City
    UPPLANDS VASBY
    State
    SE-NOTA
    Postal Code
    194 27
    Country
    SE
    Correspondent
    Tomas - Skeppmark

    US Agent

    Business Name
    DIRECTA INC.
    Contact Name
    Frank Cortes
    Address
    64, Barnebas Rd, Unit 5
    City
    Newtown
    State
    CT
    ZIP
    06470
    Country
    US
    Email
    [email protected]
    Phone
    203 4912273

    Products

    Device Name Product Code
    Resin, Root Canal Filling KIF

    Proprietary Names

    SendoCem MTA

    Establishment Types

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