510(k) Report

FDA applicant

Cooley Consulting, Inc.

Wyoming, OH1 decision2014–20140 recalls

FDA records 1 decision for Cooley Consulting, Inc. (Wyoming, OH) in 2014: 1 510(k) clearance. All are in product code PHR (Diammine Silver Fluoride Dental…). 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 Cooley Consulting, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Cooley Consulting, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PHRDiammine Silver Fluoride Dental Hypersensitivity Varnish1decision

Who builds on its devices?

Later devices cite its devices 6 times; 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.

  • K102973Silver Dental ArrestCooley Consulting, Inc. · 20146cite it

What has FDA decided for it lately?

  • K102973Silver Dental ArrestCooley Consulting, Inc. · 2014

The one decision as Cooley Consulting, Inc. →

Other applicant names beginning “Cooley”

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

Cooley & Cooley, Ltd. 1