Cleared Traditional

K141018 - ORAL-B TEST DRIVE POWER BRUSH TRIAL PRO...

K141018 is the FDA 510(k) clearance for ORAL-B TEST DRIVE POWER BRUSH TRIAL PRO... by Procter & Gamble Co.. It is a Class 1 Dental device (product code JEQ) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K141018 · Procter & Gamble Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
147d
Days
Class 1
Risk

K141018 is an FDA 510(k) clearance for the ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOT.... Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Procter & Gamble Co. (Mason, US). The FDA issued a Cleared decision on September 15, 2014 after a review of 147 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.

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Submission Details

510(k) Number K141018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2014
Decision Date September 15, 2014
Days to Decision 147 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
20d slower than avg
Panel avg: 127d · This submission: 147d
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.

Regulatory Peers - JEQ Toothbrush, Powered

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