Helioseal F Plus— 510(k) K190339

Substantially Equivalent

Ivoclar Vivadent, AG

FDA 510(k) clearance K190339 for Helioseal F Plus, Substantially Equivalent on 2019-07-29. Applicant: Ivoclar Vivadent, AG. Device class: 2.

Clearance details

Applicant: Ivoclar Vivadent, AG
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 2019-02-14
Decision date: 2019-07-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Schaan, LI

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.