Cleared Traditional

Oral-B 5% Sodium Fluoride Varnish

K153334 · Young Dental Manufacturing Co. 1, LLC · Dental
May 2016
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K153334 is an FDA 510(k) clearance for the Oral-B 5% Sodium Fluoride Varnish, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on May 20, 2016, 183 days after receiving the submission on November 19, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K153334 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2015
Decision Date May 20, 2016
Days to Decision 183 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LBH — Varnish, Cavity
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3260

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