FDA 510(k)

DentCare Aligners

Número K: K222918 · 2022-11-25

RequerenteDentcare Dental Lab Pvt , Ltd.

Data da decisão2022-11-25

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DentCare Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Dentcare Dental Lab Pvt , Ltd.. It received FDA 510(k) clearance on 2022-11-25 under 510(k) number K222918. 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 DentCare Aligners?

DentCare Aligners is a medical device that received FDA 510(k) clearance on 2022-11-25. The listed applicant is Dentcare Dental Lab Pvt , Ltd.. The 510(k) number is K222918.

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

DentCare Aligners received FDA 510(k) clearance on 2022-11-25, under 510(k) number K222918.

Who is the listed applicant for DentCare Aligners?

The FDA 510(k) record lists Dentcare Dental Lab Pvt , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DentCare Aligners?

The FDA product code for DentCare Aligners is NXC.

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Dispositivos Relacionados (Código: NXC)

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Fonte oficial

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