510(k) Report

FDA applicant

Dental Systems.Com, Inc.

Heathrow, FL2 decisions2000–20020 recalls

FDA records 2 decisions for Dental Systems.Com, Inc. (Heathrow, FL) from 2000 to 2002: 2 510(k) clearances. All are in product code EBZ (Activator, Ultraviolet, For Polymerization). 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 Dental Systems.Com, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dental Systems.Com, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dental Systems.Com, 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?

  • EBZActivator, Ultraviolet, For Polymerization2decisions

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.

  • K002925Coolblu Curing LightDental Systems.Com, Inc. · 20001cites it

What has FDA decided for it lately?

  • K020171COOLBLU2 Dental Resin Curing DeviceDental Systems.Com, Inc. · 2002
  • K002925Coolblu Curing LightDental Systems.Com, Inc. · 2000

All 2 as Dental Systems.Com, Inc. →