Cleared Traditional

DENTEK EASY BRUSH WITH FLUORIDE

K130186 · Den Tek Oral Care, Inc. · Dental
Jul 2013
Decision
171d
Days
Class 1
Risk

About This 510(k) Submission

K130186 is an FDA 510(k) clearance for the DENTEK EASY BRUSH WITH FLUORIDE, a Toothbrush, Manual (Class I — General Controls, product code EFW), submitted by Den Tek Oral Care, Inc. (Maryville, US). The FDA issued a Cleared decision on July 15, 2013, 171 days after receiving the submission on January 25, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.6855.

Submission Details

510(k) Number K130186 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EFW — Toothbrush, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6855

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