FDA 510(k)

Clear Aligners

Número K: K210373 · 2021-08-27

RequerenteShenzhen Yinuo Dental Technology Co.Ltd

Data da decisão2021-08-27

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Clear Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yinuo Dental Technology Co.Ltd. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K210373. 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 Clear Aligners?

Clear Aligners is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Shenzhen Yinuo Dental Technology Co.Ltd. The 510(k) number is K210373.

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

Clear Aligners received FDA 510(k) clearance on 2021-08-27, under 510(k) number K210373.

Who is the listed applicant for Clear Aligners?

The FDA 510(k) record lists Shenzhen Yinuo Dental Technology Co.Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clear Aligners?

The FDA product code for Clear Aligners is NXC.

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