Cleared Traditional

FluoroCal

K182917 · Bisco, Inc. · Dental
Nov 2019
Decision
395d
Days
Class 2
Risk

About This 510(k) Submission

K182917 is an FDA 510(k) clearance for the FluoroCal, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on November 18, 2019, 395 days after receiving the submission on October 19, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K182917 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2018
Decision Date November 18, 2019
Days to Decision 395 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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