Cleared Traditional

SONICWAVE SONIC PLAQUE REMOVER (K012914) - FDA 510(k) Clearance

Class I Dental device.

K012914 · Homedics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
32d
Days
Class 1
Risk

K012914 is an FDA 510(k) clearance for the SONICWAVE SONIC PLAQUE REMOVER. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Homedics, Inc. (Commerce Township, US). The FDA issued a Cleared decision on October 1, 2001 after a review of 32 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 Homedics, Inc. devices

Submission Details

510(k) Number K012914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2001
Decision Date October 01, 2001
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 127d · This submission: 32d
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.