FDA 510(k)

Magic Clear Aligners

Número K: K190948 · 2019-05-09

Data da decisão2019-05-09

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Magic Clear Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Voodoo Manufacturing, Inc.. It received FDA 510(k) clearance on 2019-05-09 under 510(k) number K190948. 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 Magic Clear Aligners?

Magic Clear Aligners is a medical device that received FDA 510(k) clearance on 2019-05-09. The listed applicant is Voodoo Manufacturing, Inc.. The 510(k) number is K190948.

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

Magic Clear Aligners received FDA 510(k) clearance on 2019-05-09, under 510(k) number K190948.

Who is the listed applicant for Magic Clear Aligners?

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

What is the FDA product code for Magic Clear Aligners?

The FDA product code for Magic Clear Aligners is NXC.

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