BEUDAMED
    FDA Registration Active 🇺🇸 United States

    THERMOPLASTIC COMFORT SYSTEMS, INC.

    Reg #: 2032807 · FEI: 3003704180 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    THERMOPLASTIC COMFORT SYSTEMS, INC.
    Registration Number
    2032807
    FEI Number
    3003704180
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2619 LIME AVENUE
    City
    SIGNAL HILL
    State
    CA
    ZIP
    90755
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053060

    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
    Cleanser, Denture, Over The Counter EFT

    Proprietary Names

    Unbreakable by TCS iFlex by TCS Karadent by TCS TCS Fresh Concentrated Dental Appliance Cleaner

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198