Cleared Traditional

K130186 - DENTEK EASY BRUSH WITH FLUORIDE

K130186 is an FDA 510(k) clearance for DENTEK EASY BRUSH WITH FLUORIDE, manufactured by Den Tek Oral Care, Inc.. The device is a Class 1 Dental device with product code EFW cleared through the Traditional 510(k) pathway after a 171-day FDA review.

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

FDA 510(k) Submission Details - K130186

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.

EFW Device Classification - Class 1, General Controls

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.

Regulatory Peers - EFW Toothbrush, Manual

All 7
Devices cleared under the same product code (EFW) and FDA review panel - the closest regulatory comparables to K130186.
LAZERSMILE, LAZERWHITE
K000290 · Biolase Technology, Inc. · Apr 2000
CREST TOOTHBRUSH WITH MICROSHIELD
K973236 · Procter & Gamble Co. · Mar 1998
REACH ANTIBACTERIAL TOOTHBRUSH
K971589 · Personal Products Co. · Jul 1997
ORALCHEK SUPER-SOFT BRUSH
K892264 · Pfizer, Inc. · Jun 1989
REACH* TOOTHBRUSH
K834580 · Johnson & Johnson Professionals, Inc. · Feb 1984
TOOTHBRUSH, REACH
K770749 · Johnson & Johnson Professionals, Inc. · Jun 1977