510(k) Report

FDA applicant

Thermoelastic Technologies, Inc.

Appollo Beach, FL2 decisions2000–20010 recalls

FDA records 2 decisions for Thermoelastic Technologies, Inc. (Appollo Beach, FL) from 2000 to 2001: 2 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and EJF (Bracket, Metal, Orthodontic). Its devices cite 1 predicate, 0 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 Thermoelastic Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Thermoelastic Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Thermoelastic Technologies, 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, Rebasing1decision
  • EJFBracket, Metal, Orthodontic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K012882Bitem Angel Reline Kit, Bitem Laboratory Kit, Models 120110, 120060Thermoelastic Technologies, Inc. · 2001
  • K994357Bitem Lock, Models SW006, SW012Thermoelastic Technologies, Inc. · 2000

All 2 as Thermoelastic Technologies, Inc. →