510(k) Report

FDA applicant

Heatshield, Inc.

New Rochelle, NY1 decision2001–20010 recalls

FDA records 1 decision for Heatshield, Inc. (New Rochelle, NY) in 2001: 1 510(k) clearance. All are in product code EAT (Tester, Pulp). 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 Heatshield, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Heatshield, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Heatshield, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EATTester, Pulp1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K011666ChillitHeatshield, Inc. · 20011cites it

What has FDA decided for it lately?

  • K011666ChillitHeatshield, Inc. · 2001

The one decision as Heatshield, Inc. →