FDA 510(k)

Inman Digital Clear Aligners

Número K: K210763 · 2021-09-29

RequerenteInman Orthodontic Laboratories, Inc.

Data da decisão2021-09-29

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Inman Digital Clear Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Inman Orthodontic Laboratories, Inc.. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K210763. 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 Inman Digital Clear Aligners?

Inman Digital Clear Aligners is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Inman Orthodontic Laboratories, Inc.. The 510(k) number is K210763.

When did Inman Digital Clear Aligners receive FDA 510(k) clearance?

Inman Digital Clear Aligners received FDA 510(k) clearance on 2021-09-29, under 510(k) number K210763.

Who is the listed applicant for Inman Digital Clear Aligners?

The FDA 510(k) record lists Inman Orthodontic Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inman Digital Clear Aligners?

The FDA product code for Inman Digital Clear Aligners is NXC.

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Fonte oficial

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