Cleared Traditional

OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02 (K901963) - FDA 510(k) Clearance

Class I Dental device.

K901963 · Omron Marshall Products, Inc. · Dental device
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Jun 1990
Decision
56d
Days
Class 1
Risk

K901963 is an FDA 510(k) clearance for the OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Omron Marshall Products, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on June 26, 1990 after a review of 56 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 Omron Marshall Products, Inc. devices

Submission Details

510(k) Number K901963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1990
Decision Date June 26, 1990
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.