Cleared Traditional

K040416 - SONICARE ADVANCE TOOTHBRUSH

K040416 is an FDA 510(k) clearance for SONICARE ADVANCE TOOTHBRUSH, manufactured by Philips Oral Healthcare, Inc.. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K040416 · Philips Oral Healthcare, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
135d
Days
Class 1
Risk

K040416 is an FDA 510(k) clearance for the SONICARE ADVANCE TOOTHBRUSH, MODEL 4900. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Philips Oral Healthcare, Inc. (Snoqualmie, US). The FDA issued a Cleared decision on July 2, 2004 after a review of 135 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 Philips Oral Healthcare, Inc. devices

FDA 510(k) Submission Details - K040416

510(k) Number K040416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2004
Decision Date July 02, 2004
Days to Decision 135 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
8d slower than avg
Panel avg: 127d · This submission: 135d
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 7
Devices cleared under the same product code (JEQ) and FDA review panel - the closest regulatory comparables to K040416.
Oral-B iO Test Drive Power Brush Trial Program Kit
K200881 · The Procter & Gamble Company · Aug 2020
ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
K141018 · Procter & Gamble Co. · Sep 2014
JENERIC/PENTRON P0WERED TOOTHBRUST
K944084 · Jeneric/Pentron, Inc. · Dec 1994
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K935561 · Bausch & Lomb, Inc. · Jan 1994
OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142
K926246 · Omron Healthcare, Inc. · Apr 1993
OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005
K926247 · Omron Healthcare, Inc. · Apr 1993