Manufacturer registered with FDA
Thermoplastic Comfort Systems, Inc.
Signal Hill, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 32006–2015
- Markets registered in
- 58 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name Thermoplastic Comfort Systems, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Thermoplastic Comfort Systems, Inc. | 3 clearances | 2006–2015 | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | Thermoplastic Comfort Systems, Inc. | 3 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Thermoplastic Comfort Systems, Inc. | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Thermoplastic Comfort Systems, Inc. | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Thermoplastic Comfort Systems | 1 | 2019–2019 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Thermoplastic Comfort Systems, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | iFlex by TCSKaradent by TCSUnbreakable by TCS | 2003 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | TCS Fresh Concentrated Dental Appliance Cleaner | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Thermoplastic Comfort Systems, Inc. as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| THERMOPLASTIC COMFORT SYSTEMS, INC.FDA reg. 2032807 | SIGNAL HILL, CA, United States | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9058150). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.