Cleared Traditional

K945248 - HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH

K945248 is an FDA 510(k) clearance for HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH, manufactured by Hukuba Dental Corp.. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K945248 · Hukuba Dental Corp. · Dental device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K945248

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.

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 10
Devices cleared under the same product code (JEQ) and FDA review panel - the closest regulatory comparables to K945248.
ORAL-B SONIC COMPLETE
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K935561 · Bausch & Lomb, Inc. · Jan 1994
OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142
K926246 · Omron Healthcare, Inc. · Apr 1993