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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 128d · 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 29
Devices cleared under the same product code (EFW) and FDA review panel - the closest regulatory comparables to K130186.
BEAM BRUSH/BEAM APP
K121165 · Beam Technologies, LLC · Jun 2012
SILVER CARE ANITBACTERIAL TOOTHBRUSH
K102871 · Piave Spazzolificio S.P.A. · Oct 2011
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
K073224 · Procter & Gamble · Feb 2008
ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
K021383 · Agion Technologies, LLC · Jul 2002
MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
K020776 · Coronet Group North America, LLC · Jun 2002
LAZERSMILE, LAZERWHITE
K000290 · Biolase Technology, Inc. · Apr 2000
K130186 · DENTEK EASY BRUSH WITH FLUORIDE
Download PDF FDA Summary Den Tek Oral Care, In…