Cleared Traditional

K943942 - TRAV-LER KIT

K943942 is an FDA 510(k) clearance for TRAV-LER KIT, 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 208-day FDA review.

K943942 · John O. Butler Co. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
208d
Days
Class 1
Risk

K943942 is an FDA 510(k) clearance for the TRAV-LER KIT. 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 March 8, 1995 after a review of 208 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K943942

510(k) Number K943942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 12, 1994
Decision Date March 08, 1995
Days to Decision 208 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 128d · This submission: 208d
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 42
Devices cleared under the same product code (JEQ) and FDA review panel - the closest regulatory comparables to K943942.
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
K022900 · John O. Butler Co. · Nov 2002
SONICWAVE SONIC PLAQUE REMOVER
K012914 · Homedics, Inc. · Oct 2001
POWERED TOOTHBRUSH
K970381 · Emjoi Action USA, Ltd. · Apr 1997
HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH
K945248 · Hukuba Dental Corp. · Jan 1995
JENERIC/PENTRON P0WERED TOOTHBRUST
K944084 · Jeneric/Pentron, Inc. · Dec 1994
PEMBUSH
K942634 · Crossroads Trading Co. · Sep 1994
K943942 · TRAV-LER KIT
Download PDF FDA Summary John O. Butler Co.