BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EndoPilot

    Reg #: 3018783058 · FEI: 3018783058 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SCHLUMBOHM GMBH & CO. KG
    Registration Number
    3018783058
    FEI Number
    3018783058
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Klein Floyen 8-10
    City
    Brokstedt Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K202906

    Owner / Operator

    Firm Name
    Schlumbohm GmbH & Co. KG
    Operator Number
    10081593
    Address
    Klein Floyen 8-10
    City
    Brokstedt
    State
    Schleswig-Holstein
    Postal Code
    24616
    Country
    DE
    Correspondent
    Gerald Schlumbohm

    US Agent

    Business Name
    Komet USA LLC
    Contact Name
    Imke Lindenbeck
    Address
    1057 Red Ventures Dr, Suite 100
    City
    Fort Mill
    State
    SC
    ZIP
    29707
    Country
    US
    Email
    [email protected]
    Phone
    888 5663887

    Products

    Device Name Product Code
    Scaler, Ultrasonic ELC
    Handpiece, Direct Drive, Ac-Powered EKX
    Locator, Root Apex LQY
    Plugger, Root Canal, Endodontic EKR

    Proprietary Names

    EndoPilot

    Establishment Types

    Manufacture Medical Device