THERMOPLASTIC COMFORT SYSTEMS, INC.

FDA Device Registration & Listing · SIGNAL HILL, CA, US · Registration 2032807

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2032807
FEI Number
3003704180
Entity Name
THERMOPLASTIC COMFORT SYSTEMS, INC.
City/State/Country
SIGNAL HILL, CA, US
Establishment Address
2619 LIME AVENUE, SIGNAL HILL, CA 90755, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
THERMOPLASTIC COMFORT SYSTEMS, INC. (Owner Number: 9058150)
Owner / Operator Contact Address
2619 LIME AVENUE, --, Signal Hill, CA 90755, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K142894
PMA Number
N/A

All Registered Proprietary Names

Unbreakable by TCS iFlex by TCS Karadent by TCS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2003-08-20
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2013-04-20
MQC Mouthguard, Prescription Unknown Class U N/A 2013-04-20
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2015-10-20

Official Correspondent

MARILIN POSCA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

THERMOPLASTIC COMFORT SYSTEMS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K800400 Dentsply Intl. MAXUM DENTURE RESIN 1980-03-12
K033020 Cmp Industries, LLC IMPAK ACRYLIC REPAIR RESIN LIQUID 2003-12-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032807. Last updated year: 2026. Please use registration number 2032807 when referencing this establishment in official correspondence.
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