BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    ceramic, orthodontic bracket

    Reg #: 9616044 · FEI: 3002336796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SPT ROTH LTD.
    Registration Number
    9616044
    FEI Number
    3002336796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    WERKSTRASSE 28
    City
    LYSS Bern
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K110335

    Owner / Operator

    Firm Name
    SPT ROTH LTD.
    Operator Number
    9043481
    Address
    Werkstrasse 28
    City
    Lyss
    State
    Bern
    Postal Code
    CH-3250
    Country
    CH

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Bracket, Ceramic, Orthodontic NJM

    Proprietary Names

    ceramic, orthodontic bracket

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device