510(k) Report

FDA applicant

John O. Butler Co.

Chicago, IL6 decisions1987–20020 recalls

FDA records 6 decisions for John O. Butler Co. (Chicago, IL) from 1987 to 2002: 6 510(k) clearances. Most are in product codes JEQ (Toothbrush, Powered) and EFW (Toothbrush, Manual). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “John O. Butler”.

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 John O. Butler Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for John O. Butler Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “John”

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