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Thermoplastic Comfort Systems, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000025565 FEI 3003704180

Devices
214
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI

What Thermoplastic Comfort Systems, Inc. makes

Thermoplastic Comfort Systems, Inc. manufactures dental appliance cleaning solutions, including single-use and bulk packaging for disinfecting removable dental devices. Their product line also includes reusable dental appliances designed for durability, such as the I.FLEX and UNBREAKABLE series, as well as a blend system for mixing cleaning agents.

The company’s portfolio includes devices classified as Class I and Class II under regulatory frameworks, with listings in the EU’s EUDAMED database and the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue214

Newest first, rows 1-50 of 214

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  • iFlex by TCS Ref 5000-01/MF Custom

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5002-01/S4

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4005-01/LFN

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5003-01B/4X10

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5000/D98x20-2

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4000-01/MF2

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4000-01/MN

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4000-01/M3

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5003-01B/4X5

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5003-01 /B Custom

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4002-01/S Custom

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5003-01B/Custom-.5

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5005-01/LF3

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Karadent by TCS Ref 2000-01/M1

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Karadent by TCS Ref 2003-01B/4-.5

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4005-01/L22 Custom

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5003-01B/2X10

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Karadent by TCS Ref 2003-01/BN

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4003-01B/N-.5

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5000-01/S Custom

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4003-01B/3X5

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Karadent by TCS Ref 2003-01B/Custom-.5

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5005-01/M22-2

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5005-01/L2

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5003-01/B2

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4005-01/L3

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5003-01B/2X5

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Karadent by TCS Ref 2000-01/S1

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5000-01/M4

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4000/D98x25-2

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5002-01/S1

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5003-01B/NX5

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4005-01/M22-2

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5002-01/SN

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5005-01/M22 Custom

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4005-01/L Custom

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5005-01/M22-4

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4003-01B/4-.5

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Karadent by TCS Ref 2000-01/M4

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5005-01/L22 Custom

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4005-01/M22-1

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Karadent by TCS Ref 2005-01/LF1

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4003-01B/2X10

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Karadent by TCS Ref 2000-01/M2

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Karadent by TCS Ref 2005-01/M22-2

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4005-01/M22-4

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Karadent by TCS Ref 2000-01/MF1

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • iFlex by TCS Ref 5000/D98x20-N

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Unbreakable by TCS Ref 4003-01/B4

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Karadent by TCS Ref 2003-01/B Custom

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 1-50 of 214

Showing 1-50 of 214

Company details

EUDAMED SRN
US-MF-000025565
FDA FEI number
3003704180
EUDAMED status
Active
EUDAMED registered name
Thermoplastic Comfort Systems, Inc.
EUDAMED abbreviated name
TCS, Inc.
Registered address
2619, Lime Ave, 90755, Signal Hill, CA, United States
Phone
562 426 2970
PRRC contact
Ubaldo Anaya(public in EUDAMED)

From the company website

Read 18 Oct 2026

TCS Dental crafts high-quality, aesthetic, and durable removable dental appliances using BPA/monomer-free thermoplastic resins. ISO Certified & USA-made.

From the manufacturer's own website, in their original language. Source

Frequently asked questions

How many devices does Thermoplastic Comfort Systems, Inc. have in the registry?

The registry currently lists 214 devices for Thermoplastic Comfort Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Thermoplastic Comfort Systems, Inc.'s devices?

Among its 50 most recently registered devices, Thermoplastic Comfort Systems, Inc. has devices listed in EUDAMED (50 devices).

What risk classes do Thermoplastic Comfort Systems, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Thermoplastic Comfort Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Thermoplastic Comfort Systems, Inc. in the registry?

The most recently registered devices listed for Thermoplastic Comfort Systems, Inc. include iFlex by TCS, Unbreakable by TCS and Karadent by TCS.

Generated automatically from registry data and not verified by a human reviewer.