Cleared Traditional

K012914 - SONICWAVE SONIC PLAQUE REMOVER

K012914 is an FDA 510(k) clearance for SONICWAVE SONIC PLAQUE REMOVER, manufactured by Homedics, Inc.. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K012914 · Homedics, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K012914

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 128d · This submission: 32d
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 53
Devices cleared under the same product code (JEQ) and FDA review panel - the closest regulatory comparables to K012914.
ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
K061199 · Braun GmbH · May 2006
SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
K040416 · Philips Oral Healthcare, Inc. · Jul 2004
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
K022900 · John O. Butler Co. · Nov 2002
POWERED TOOTHBRUSH
K970381 · Emjoi Action USA, Ltd. · Apr 1997
TRAV-LER KIT
K943942 · John O. Butler Co. · Mar 1995
HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH
K945248 · Hukuba Dental Corp. · Jan 1995
K012914 · SONICWAVE SONIC PLAQUE REMOVER
Download PDF FDA Summary Homedics, Inc.