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FDA 510(k)

ArgenZ HT+

K-Number: K190079 · 2019-04-12

ApplicantThe Argen Corporation
Decision Date2019-04-12
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ArgenZ HT+ is a medical device manufactured by The Argen Corporation. It received FDA 510(k) clearance on 2019-04-12 under approval 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. It is manufactured by The Argen Corporation. The 510(k) number is K190079.

When was ArgenZ HT+ approved by the FDA?

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

What company makes ArgenZ HT+?

ArgenZ HT+ is manufactured by The Argen Corporation.

What is the FDA product code for ArgenZ HT+?

The FDA product code for ArgenZ HT+ is EIH.

Other Devices by The Argen Corporation

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

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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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