510(k) Report

FDA applicant

Stephen M Koral, Dmd

Boulder, CO2 decisions2001–20020 recalls

FDA records 2 decisions for Stephen M Koral, Dmd (Boulder, CO) from 2001 to 2002: 2 510(k) clearances. Most are in product codes EIK (Carver, Wax, Dental) and EJK (Liner, Cavity, Calcium Hydroxide). 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 Stephen M Koral, Dmd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stephen M Koral, Dmd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stephen M Koral, Dmd 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?

  • EIKCarver, Wax, Dental1decision
  • EJKLiner, Cavity, Calcium Hydroxide1decision

What has FDA decided for it lately?

  • K013993NeocalexStephen M Koral, Dmd · 2002
  • K010176Calex ConditionerStephen M Koral, Dmd · 2001

All 2 as Stephen M Koral, Dmd →

Other applicant names beginning “Stephen”

FDA records each applicant name separately; these may or may not be the same firm.

Stephen Chakoff, Inc. 16Stephen A. Dunn, Inc. 2Stephen J Harkins, Dds, PC 1