Cleared Traditional

HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH (K945248) - FDA 510(k) Clearance

Class I Dental device.

K945248 · Hukuba Dental Corp. · Dental device
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Jan 1995
Decision
91d
Days
Class 1
Risk

K945248 is an FDA 510(k) clearance for the HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Hukuba Dental Corp. (Nagareyama Chiba, JP). The FDA issued a Cleared decision on January 26, 1995 after a review of 91 days - within the typical 510(k) review window.

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.

View all Hukuba Dental Corp. devices

Submission Details

510(k) Number K945248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1994
Decision Date January 26, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
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.