Cleared Traditional

FLUOR PROTECTOR S

K131487 · Ivoclar Vivadent, AG · Dental
Oct 2014
Decision
503d
Days
Class 2
Risk

About This 510(k) Submission

K131487 is an FDA 510(k) clearance for the FLUOR PROTECTOR S, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Ivoclar Vivadent, AG (Amherst, US). The FDA issued a Cleared decision on October 8, 2014, 503 days after receiving the submission on May 23, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K131487 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2013
Decision Date October 08, 2014
Days to Decision 503 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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