Cleared Traditional

K130186 - DENTEK EASY BRUSH WITH FLUORIDE (FDA 510(k) Clearance)

Class I Dental device.

K130186 · Den Tek Oral Care, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
171d
Days
Class 1
Risk

K130186 is an FDA 510(k) clearance for the DENTEK EASY BRUSH WITH FLUORIDE. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Den Tek Oral Care, Inc. (Maryville, US). The FDA issued a Cleared decision on July 15, 2013 after a review of 171 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6855 - 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 Den Tek Oral Care, Inc. devices

Submission Details

510(k) Number K130186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2013
Decision Date July 15, 2013
Days to Decision 171 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
44d slower than avg
Panel avg: 127d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFW Toothbrush, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
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.