Is this your brand? Sign in to claim ownership.
Sign in to claim this brandTHERMOPLASTIC COMFORT SYS
US
Last updated May 24, 2026
What THERMOPLASTIC COMFORT SYS makes
Thermoplastic Comfort Systems produces thermoplastic materials used for fabricating dental appliances, including custom-fitted devices for dental and orthodontic applications. Their product line also includes denture cleansers designed to maintain oral prosthetics. Examples include thermoplastic sheets and resins for appliance fabrication, as well as cleaning solutions for dentures.
The company’s devices are classified under FDA categories, including Class I, Class II, and Unclassified (U), and are listed in the FDA’s Unique Device Identifier (UDI) database. Their portfolio is regulated under U.S. medical device laws, and the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- tcsdentalinc.com
- —
- —
- [email protected]
- Phone
- 562-426-2970
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 808897776
Catalogue (296)
Page 2 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iFlex by TCS | 5005-JP/S4 | FDA UDI | Class II | Active |
| iFlex by TCS | 5003-01/B4 | FDA UDI | U | Active |
| iFlex by TCS | 5005-01/L3 | FDA UDI | Class II | Active |
| Karadent by TCS | 2005-01/LT25-2 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4005-01/LF Custom | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4003-01/B3 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4000-01/M2 | FDA UDI | Class II | Active |
| Karadent by TCS | 2000-01B-Custom | FDA UDI | Class II | Active |
| Karadent by TCS | 2003-01BN-.5 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4005-JP/L1 | FDA UDI | Class II | Active |
| Karadent by TCS | 2002-JP/S4 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4005-01/L3 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4000-01/MF4 | FDA UDI | Class II | Active |
| iFlex by TCS | 5003-01B/3X5 | FDA UDI | U | Active |
| iFlex by TCS | 5005-JP/L1 | FDA UDI | U | Active |
| Unbreakable by TCS | 4000-01/MF3 | FDA UDI | Class II | Active |
| iFlex by TCS | 5003-01B/4X10 | FDA UDI | Class II | Active |
| Karadent by TCS | 2000-01/MF1 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4002-JP/S-Custom | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4005-01/MT25-2 | FDA UDI | Class II | Active |
| Karadent by TCS | 2003-01/B Custom | FDA UDI | Class II | Active |
| Karadent by TCS | 2005-01/LF3 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4003-01/B1 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4005-01/LT25-2 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4000/D98x25-N | FDA UDI | Class II | Active |
| iFlex by TCS | 5005-01/L Custom | FDA UDI | U | Active |
| Unbreakable by TCS | 4005-01/LT25 Custom | FDA UDI | Class II | Active |
| iFlex by TCS | 5005-JP/SN | FDA UDI | Class II | Active |
| iFlex by TCS | 5000-01/MFN | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4003-01B/2X5 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4002-JP/S4 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4005-01/LF2 | FDA UDI | Class II | Active |
| Karadent by TCS | 2002-JP/S-Custom | FDA UDI | Class II | Active |
| iFlex by TCS | 5002-01/S4 | FDA UDI | U | Active |
| iFlex by TCS | 5002-01/S1 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4005-01/LNZ25-N | FDA UDI | Class II | Active |
| Karadent by TCS | 2005-01/LF-Custom | FDA UDI | Class II | Active |
| Karadent by TCS | 2005-01/MT25-2 | FDA UDI | Class II | Active |
| iFlex by TCS | 5005-01/LFN | FDA UDI | Class II | Active |
| iFlex by TCS | 5005-01/L22-2 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4000-01/M4 | FDA UDI | Class II | Active |
| iFlex by TCS | 5003-01B/4-.5 | FDA UDI | Class II | Active |
| Karadent by TCS | 2003-01B/4X10 | FDA UDI | Class II | Active |
| Karadent by TCS | 2000-01/SN | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4000/D98x20-3 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4005-01/LT25-N | FDA UDI | Class II | Active |
| iFlex by TCS | 5000-01/M1 | FDA UDI | Class II | Active |
| Unbreakable by TCS | 4000-01/MN | FDA UDI | Class II | Active |
| iFlex by TCS | 5005-01/MT25-3 | FDA UDI | Class II | Active |
| iFlex by TCS | 5000-01/M2 | FDA UDI | U | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.