Data / Medical devices / United States / Thermoplastic Comfort Systems, Inc.
Thermoplastic Comfort Systems, Inc.: FDA-registered device maker in Signal Hill, CA, United States, 3 510(k) clearances
Thermoplastic Comfort Systems, Inc. is registered with the FDA (registration 2032807) in Signal Hill, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 3, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2032807
- FEI number
- 3003704180
- Address
- 2619 Lime Avenue, Signal Hill, CA, United States, 90755
- Owner or operator
- THERMOPLASTIC COMFORT SYSTEMS, INC. (9058150)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 20, 2003
- Registered through
- 2027
- Brand names listed
- Karadent by TCS, TCS Fresh Concentrated Dental Appliance Cleaner, Unbreakable by TCS, iFlex by TCS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleanser, Denture, Over The Counter | EFT | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 3, 2015 | K142894 | TCS Blend | EBI | Substantially Equivalent | Thermoplastic Comfort Systems, Inc. | accessdata.fda.gov |
| January 10, 2013 | K123396 | I.FLEX BY TCS | EBI | Substantially Equivalent | Thermoplastic Comfort Systems, Inc. | accessdata.fda.gov |
| July 20, 2006 | K053060 | TCS UNBREAKABLE | EBI | Substantially Equivalent | Thermoplastic Comfort Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cleanser, Denture, Over The Counter
- All makers of Mouthguard, Prescription
- All makers of Resin, Denture, Relining, Repairing, Rebasing
Updated February 3, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.