FDA 510(k)

Concinnity Aligners

Número K: K200005 · 2020-11-09

RequerenteDrake Precision Dental Laboratory, Inc.

Data da decisão2020-11-09

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Concinnity Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Drake Precision Dental Laboratory, Inc.. It received FDA 510(k) clearance on 2020-11-09 under 510(k) number K200005. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Concinnity Aligners?

Concinnity Aligners is a medical device that received FDA 510(k) clearance on 2020-11-09. The listed applicant is Drake Precision Dental Laboratory, Inc.. The 510(k) number is K200005.

When did Concinnity Aligners receive FDA 510(k) clearance?

Concinnity Aligners received FDA 510(k) clearance on 2020-11-09, under 510(k) number K200005.

Who is the listed applicant for Concinnity Aligners?

The FDA 510(k) record lists Drake Precision Dental Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Concinnity Aligners?

The FDA product code for Concinnity Aligners is NXC.

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