Cleared Traditional

Cervitec F

K191453 · Ivoclar Vivadent, AG · Dental
Feb 2020
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K191453 is an FDA 510(k) clearance for the Cervitec F, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on February 11, 2020, 256 days after receiving the submission on May 31, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K191453 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2019
Decision Date February 11, 2020
Days to Decision 256 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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