Cleared Traditional

CERVITEC PLUS

K072338 · Ivoclar Vivadent, Inc. · Dental
Sep 2007
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K072338 is an FDA 510(k) clearance for the CERVITEC PLUS, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on September 21, 2007, 32 days after receiving the submission on August 20, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K072338 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 2007
Decision Date September 21, 2007
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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

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