FDA 510(k)

Arcad SmileStudio and Aligner System

Número K: K192244 · 2020-05-11

Data da decisão2020-05-11

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Arcad SmileStudio and Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is Arcadlab. It received FDA 510(k) clearance on 2020-05-11 under 510(k) number K192244. 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 Arcad SmileStudio and Aligner System?

Arcad SmileStudio and Aligner System is a medical device that received FDA 510(k) clearance on 2020-05-11. The listed applicant is Arcadlab. The 510(k) number is K192244.

When did Arcad SmileStudio and Aligner System receive FDA 510(k) clearance?

Arcad SmileStudio and Aligner System received FDA 510(k) clearance on 2020-05-11, under 510(k) number K192244.

Who is the listed applicant for Arcad SmileStudio and Aligner System?

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

What is the FDA product code for Arcad SmileStudio and Aligner System?

The FDA product code for Arcad SmileStudio and Aligner System is NXC.

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