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FDA 510(k)

Helioseal F Plus

K-Number: K190339 · 2019-07-29

ApplicantIvoclar Vivadent, AG
Decision Date2019-07-29
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Helioseal F Plus is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2019-07-29 under 510(k) number K190339. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Helioseal F Plus?

Helioseal F Plus is a medical device that received FDA 510(k) clearance on 2019-07-29. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K190339.

When did Helioseal F Plus receive FDA 510(k) clearance?

Helioseal F Plus received FDA 510(k) clearance on 2019-07-29, under 510(k) number K190339.

Who is the listed applicant for Helioseal F Plus?

The FDA 510(k) record lists Ivoclar Vivadent, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Helioseal F Plus?

The FDA product code for Helioseal F Plus is EBC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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