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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

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 the device name listed in this FDA 510(k) record. The listed applicant is The Argen Corporation. It received FDA 510(k) clearance on 2019-02-08 under 510(k) 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. The listed applicant is The Argen Corporation. The 510(k) number is K182833.

When did ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer receive FDA 510(k) clearance?

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

Who is the listed applicant for ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer?

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 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.

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.

Related Devices (Code: EIH)

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.

Official Source

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