FDA 510(k)

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

Número K: K182833 · 2019-02-08

Data da decisão2019-02-08

Código do produtoEIH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam The Argen Corporation como candidato(a)

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Fonte oficial

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