FDA 510(k)

ArgenZ HT+

K-Number: K190079 · 2019-04-12

Decision Date2019-04-12

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ArgenZ HT+ is the device name listed in this FDA 510(k) record. The listed applicant is The Argen Corporation. It received FDA 510(k) clearance on 2019-04-12 under 510(k) number K190079. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArgenZ HT+?

ArgenZ HT+ is a medical device that received FDA 510(k) clearance on 2019-04-12. The listed applicant is The Argen Corporation. The 510(k) number is K190079.

When did ArgenZ HT+ receive FDA 510(k) clearance?

ArgenZ HT+ received FDA 510(k) clearance on 2019-04-12, under 510(k) number K190079.

Who is the listed applicant for ArgenZ HT+?

The FDA 510(k) record lists The Argen Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArgenZ HT+?

The FDA product code for ArgenZ HT+ is EIH.

Other records listing The Argen Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182833ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer

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Official Source

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