Cleared Abbreviated

Helioseal F Plus

K190339 · Ivoclar Vivadent, AG · Dental
Jul 2019
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K190339 is an FDA 510(k) clearance for the Helioseal F Plus, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on July 29, 2019, 165 days after receiving the submission on February 14, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K190339 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2019
Decision Date July 29, 2019
Days to Decision 165 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBC — Sealant, Pit And Fissure, And Conditioner
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3765

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