FDA 510(k)

Al Smile Aligner

Número K: K222308 · 2022-12-20

RequerenteNanjing Jiahe Dental Technology Co., Ltd.

Data da decisão2022-12-20

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Al Smile Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Jiahe Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-20 under 510(k) number K222308. 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 Al Smile Aligner?

Al Smile Aligner is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Nanjing Jiahe Dental Technology Co., Ltd.. The 510(k) number is K222308.

When did Al Smile Aligner receive FDA 510(k) clearance?

Al Smile Aligner received FDA 510(k) clearance on 2022-12-20, under 510(k) number K222308.

Who is the listed applicant for Al Smile Aligner?

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

What is the FDA product code for Al Smile Aligner?

The FDA product code for Al Smile Aligner is NXC.

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Fonte oficial

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