Cleared Traditional

SMARTCOAT 2.5% NAF VARNISH

K131376 · Elevate Oral Care · Dental
Aug 2013
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K131376 is an FDA 510(k) clearance for the SMARTCOAT 2.5% NAF VARNISH, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Elevate Oral Care (West Palm Beach, US). The FDA issued a Cleared decision on August 27, 2013, 105 days after receiving the submission on May 14, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K131376 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2013
Decision Date August 27, 2013
Days to Decision 105 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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