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THERMOPLASTIC COMFORT SYS

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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 562-426-2970
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 808897776

Catalogue (296)

Page 3 of 6

Device	Model / Reference	Registries	Class	Status
Unbreakable by TCS	4003-01B/2X10	FDA UDI	Class II	Active
Karadent by TCS	2005-01/LT25-Custom	FDA UDI	Class II	Active
iFlex by TCS	5000-01/MF1	FDA UDI	Class II	Active
Unbreakable by TCS	4005-01/M22-N	FDA UDI	Class II	Active
iFlex by TCS	5003-01BN-.5	FDA UDI	Class II	Active
iFlex by TCS	5005-JP/S1	FDA UDI	U	Active
iFlex by TCS	5003-01/BN	FDA UDI	Class II	Active
Unbreakable by TCS	4005-01/M22-1	FDA UDI	Class II	Active
iFlex by TCS	5005-01/M22 Custom	FDA UDI	U	Active
Karadent by TCS	2003-01B/ CustomX10	FDA UDI	Class II	Active
iFlex by TCS	5005-JP/L2	FDA UDI	Class II	Active
Karadent by TCS	2005-01/L22-2	FDA UDI	Class II	Active
Karadent by TCS	2005-01/LF4	FDA UDI	Class II	Active
iFlex by TCS	5000-01/MF3	FDA UDI	Class II	Active
iFlex by TCS	5000-01/M4	FDA UDI	U	Active
Unbreakable by TCS	4005-01/LNZ25-1	FDA UDI	Class II	Active
iFlex by TCS	5005-01LT25 Custom	FDA UDI	U	Active
Unbreakable by TCS	4005-01/L1	FDA UDI	Class II	Active
iFlex by TCS	5005-01/M22-2	FDA UDI	U	Active
Karadent by TCS	2005-01/LNZ25-2	FDA UDI	Class II	Active
Unbreakable by TCS	4003-01B/ CustomX5	FDA UDI	Class II	Active
Karadent by TCS	2003-01B/NX10	FDA UDI	Class II	Active
Unbreakable by TCS	4005-01/LT25-3	FDA UDI	Class II	Active
iFlex by TCS	5003-01B/ Custom-.5	FDA UDI	U	Active
iFlex by TCS	5003-01B/2X5	FDA UDI	Class II	Active
Karadent by TCS	2005-01/LNZ25-Custom	FDA UDI	Class II	Active
Unbreakable by TCS	4005-01/L22 Custom	FDA UDI	Class II	Active
iFlex by TCS	5003-01B/2-.5	FDA UDI	Class II	Active
Unbreakable by TCS	4003-01B/1.5	FDA UDI	Class II	Active
Karadent by TCS	2003-01/B2	FDA UDI	Class II	Active
iFlex by TCS	5005-01MT25 Custom	FDA UDI	Class II	Active
Unbreakable by TCS	4003-01B/ Custom-.5	FDA UDI	Class II	Active
Unbreakable by TCS	4000-01/M1	FDA UDI	Class II	Active
Unbreakable by TCS	4002-JP/S3	FDA UDI	Class II	Active
iFlex by TCS	5005-JP/L Custom	FDA UDI	U	Active
iFlex by TCS	5003-01/B Custom	FDA UDI	U	Active
iFlex by TCS	5005-01/LF1	FDA UDI	Class II	Active
iFlex by TCS	5003-01B/CustomX10	FDA UDI	U	Unknown
iFlex by TCS	5005-JP/S3	FDA UDI	U	Active
Karadent by TCS	2003-01B/1X5	FDA UDI	Class II	Active
iFlex by TCS	5003-01B/1X10	FDA UDI	U	Active
iFlex by TCS	5003-01B/CustomX10	FDA UDI	U	Active
Unbreakable by TCS	4005-JP/LCustom	FDA UDI	Class II	Active
Karadent by TCS	2000-01/MFN	FDA UDI	Class II	Active
Karadent by TCS	2000-01/M2	FDA UDI	Class II	Active
Karadent by TCS	2005-JP/L2	FDA UDI	Class II	Active
iFlex by TCS	5003-01BNX10	FDA UDI	Class II	Active
Karadent by TCS	2005-01/LNZ25-N	FDA UDI	Class II	Active
Karadent by TCS	2005-01/M22-4	FDA UDI	Class II	Active
Unbreakable by TCS	4000-01/MF Custom	FDA UDI	Class II	Active

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