510(k) Report

FDA applicant

Thermoplastic Comfort Systems, Inc.

Signal Hill, CA3 decisions2006–20150 recalls

FDA records 3 decisions for Thermoplastic Comfort Systems, Inc. (Signal Hill, CA) from 2006 to 2015: 3 510(k) clearances. All are in product code EBI (Resin, Denture, Relining, Repairing, Rebasing). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Thermoplastic Comfort Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2013: 12015: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Thermoplastic Comfort Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBIResin, Denture, Relining, Repairing, Rebasing3decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K053060TCS UnbreakableThermoplastic Comfort Systems, Inc. · 20068cite it

What has FDA decided for it lately?

  • K142894TCS BlendThermoplastic Comfort Systems, Inc. · 2015
  • K123396I.Flex by TCSThermoplastic Comfort Systems, Inc. · 2013
  • K053060TCS UnbreakableThermoplastic Comfort Systems, Inc. · 2006

All 3 as Thermoplastic Comfort Systems, Inc. →