Cleared Traditional

K970381 - POWERED TOOTHBRUSH

K970381 is an FDA 510(k) clearance for POWERED TOOTHBRUSH, manufactured by Emjoi Action USA, Ltd.. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K970381 · Emjoi Action USA, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
74d
Days
Class 1
Risk

K970381 is an FDA 510(k) clearance for the POWERED TOOTHBRUSH. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Emjoi Action USA, Ltd. (Westford, US). The FDA issued a Cleared decision on April 18, 1997 after a review of 74 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.

FDA 510(k) Submission Details - K970381

510(k) Number K970381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date April 18, 1997
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 128d · This submission: 74d
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 K970381.
SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
K040416 · Philips Oral Healthcare, Inc. · Jul 2004
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
K022900 · John O. Butler Co. · Nov 2002
SONICWAVE SONIC PLAQUE REMOVER
K012914 · Homedics, Inc. · Oct 2001
TRAV-LER KIT
K943942 · John O. Butler Co. · Mar 1995
HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH
K945248 · Hukuba Dental Corp. · Jan 1995
JENERIC/PENTRON P0WERED TOOTHBRUST
K944084 · Jeneric/Pentron, Inc. · Dec 1994
K970381 · POWERED TOOTHBRUSH
Download PDF Emjoi Action USA, Ltd.