Cleared Traditional

BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES

K022900 · John O. Butler Co. · Dental
Nov 2002
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K022900 is an FDA 510(k) clearance for the BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES, a Toothbrush, Powered (Class I — General Controls, product code JEQ), submitted by John O. Butler Co. (Chicago, US). The FDA issued a Cleared decision on November 14, 2002, 72 days after receiving the submission on September 3, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.6865.

Submission Details

510(k) Number K022900 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2002
Decision Date November 14, 2002
Days to Decision 72 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEQ — Toothbrush, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6865

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