BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iFlex by TCS

    Reg #: 2032807 · FEI: 3003704180 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    THERMOPLASTIC COMFORT SYSTEMS, INC.
    Registration Number
    2032807
    FEI Number
    3003704180
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2619 LIME AVENUE
    City
    SIGNAL HILL
    State
    CA
    ZIP
    90755
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123396

    Owner / Operator

    Firm Name
    THERMOPLASTIC COMFORT SYSTEMS, INC.
    Operator Number
    9058150
    Address
    2619 LIME AVENUE, --
    City
    Signal Hill
    State
    CA
    Postal Code
    90755
    Country
    US
    Correspondent
    MARILIN S POSCA

    Products

    Device Name Product Code
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Mouthguard, Prescription MQC

    Proprietary Names

    iFlex by TCS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device