Cleared Traditional

K022900 - BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES

K022900 is an FDA 510(k) clearance for BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES, manufactured by John O. Butler Co.. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K022900 · John O. Butler Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
72d
Days
Class 1
Risk

K022900 is an FDA 510(k) clearance for the BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by John O. Butler Co. (Chicago, US). The FDA issued a Cleared decision on November 14, 2002 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6865 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all John O. Butler Co. devices

FDA 510(k) Submission Details - K022900

510(k) Number K022900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 127d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

JEQ Device Classification - Class 1, General Controls

Product Code JEQ Toothbrush, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6865
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JEQ Toothbrush, Powered

All 8
Devices cleared under the same product code (JEQ) and FDA review panel - the closest regulatory comparables to K022900.
Oral-B iO Test Drive Power Brush Trial Program Kit
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ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
K141018 · Procter & Gamble Co. · Sep 2014
POWERED TOOTHBRUSH
K970381 · Emjoi Action USA, Ltd. · Apr 1997
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INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
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OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142
K926246 · Omron Healthcare, Inc. · Apr 1993