BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    300.4808 - SURGtorque LUX S459 L

    Reg #: 3003637274 · FEI: 3003637274 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KAVO DENTAL GMBH
    Registration Number
    3003637274
    FEI Number
    3003637274
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BAHNHOFSTRASSE 20
    City
    WARTHAUSEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K093341

    Owner / Operator

    Firm Name
    KaVo Dental GmbH
    Operator Number
    10042139
    Address
    Bismarckring 39
    City
    Biberach
    State
    Baden-Wurttemberg
    Postal Code
    88400
    Country
    DE

    US Agent

    Business Name
    KaVo Dental Technologies, LLC
    Contact Name
    Crystal Bialek
    Address
    11727 Fruehauf Drive
    City
    Charlotte
    State
    NC
    ZIP
    28273
    Country
    US
    Email
    [email protected]
    Phone
    704 2886058

    Products

    Device Name Product Code
    Handpiece, Air-Powered, Dental EFB

    Proprietary Names

    300.4808 - SURGtorque LUX S459 L 300.5063 - SURGtorque S459 C 108.1644 - SMARTtorque S609 C 108.1642 - SMARTtorque S619 C 108.1643 - SMARTtorque Mini LUX S615 L 108.1641 - SMARTtorque LUX S619 L 108.1645 - SMARTtorque Mini S605 C

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)