Cleared Traditional

HUBUKA HYG TOOTHBRUSH (K915576) - FDA 510(k) Clearance

Class I Dental device.

K915576 · Hukuba Dental Corp. · Dental device
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Mar 1994
Decision
813d
Days
Class 1
Risk

K915576 is an FDA 510(k) clearance for the HUBUKA HYG TOOTHBRUSH. Classified as Toothbrush, Ionic, Battery-powered (product code MMD), Class I - General Controls.

Submitted by Hukuba Dental Corp. (Nagareyama City, Chiba, JP). The FDA issued a Cleared decision on March 4, 1994 after a review of 813 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Hukuba Dental Corp. devices

Submission Details

510(k) Number K915576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1991
Decision Date March 04, 1994
Days to Decision 813 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
686d slower than avg
Panel avg: 127d · This submission: 813d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MMD Toothbrush, Ionic, Battery-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.