FDA 510(k)

Identic and KromaFaze Alginate Dental Impression Materials

Número K: K160441 · 2016-06-30

Data da decisão2016-06-30

Código do produtoELW

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Identic and KromaFaze Alginate Dental Impression Materials is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K160441. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Identic and KromaFaze Alginate Dental Impression Materials?

Identic and KromaFaze Alginate Dental Impression Materials is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Kerr Corporation. The 510(k) number is K160441.

When did Identic and KromaFaze Alginate Dental Impression Materials receive FDA 510(k) clearance?

Identic and KromaFaze Alginate Dental Impression Materials received FDA 510(k) clearance on 2016-06-30, under 510(k) number K160441.

Who is the listed applicant for Identic and KromaFaze Alginate Dental Impression Materials?

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

What is the FDA product code for Identic and KromaFaze Alginate Dental Impression Materials?

The FDA product code for Identic and KromaFaze Alginate Dental Impression Materials is ELW.

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Fonte oficial

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