BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Sigma Aligners

    Reg #: 3035691085 · FEI: 3035691085 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CRISTALINE ALIGNERS GMBH
    Registration Number
    3035691085
    FEI Number
    3035691085
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hanauer Strasse 1-5
    City
    Pforzheim Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K242892

    Owner / Operator

    Firm Name
    Cristaline Aligners GmbH
    Operator Number
    10092474
    Address
    Hanauer Strasse 1-5
    City
    Pforzheim
    State
    Baden-Wurttemberg
    Postal Code
    75181
    Country
    DE
    Correspondent
    Patsy J Trisler

    US Agent

    Business Name
    Trisler Consulting dba
    Contact Name
    Patsy Trisler
    Address
    306 Turnberry Ct
    City
    Lebanon
    State
    IN
    ZIP
    46052
    Country
    US
    Email
    [email protected]
    Phone
    301 7855597

    Products

    Device Name Product Code
    Aligner, Sequential NXC

    Proprietary Names

    Sigma Aligners Cristaline Aligners

    Establishment Types

    Manufacture Medical Device