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FDA 510(k)

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

K-Number: K182833 · 2019-02-08

ApplicantThe Argen Corporation
Decision Date2019-02-08
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer is a medical device manufactured by The Argen Corporation. It received FDA 510(k) clearance on 2019-02-08 under approval number K182833. 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 Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer?

ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer is a medical device that received FDA 510(k) clearance on 2019-02-08. It is manufactured by The Argen Corporation. The 510(k) number is K182833.

When was ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer approved by the FDA?

ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer received FDA 510(k) clearance on 2019-02-08, under approval number K182833.

What company makes ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer?

ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer is manufactured by The Argen Corporation.

What is the FDA product code for ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer?

The FDA product code for ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer is EIH.

Related Clinical Trials

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K190079ArgenZ HT+

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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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