FDA 510(k)

MyClearALIGN Dental Aligner System

Número K: K221475 · 2022-08-31

Data da decisão2022-08-31

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

MyClearALIGN Dental Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is Key Dental Technologies, LLC. It received FDA 510(k) clearance on 2022-08-31 under 510(k) number K221475. 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 MyClearALIGN Dental Aligner System?

MyClearALIGN Dental Aligner System is a medical device that received FDA 510(k) clearance on 2022-08-31. The listed applicant is Key Dental Technologies, LLC. The 510(k) number is K221475.

When did MyClearALIGN Dental Aligner System receive FDA 510(k) clearance?

MyClearALIGN Dental Aligner System received FDA 510(k) clearance on 2022-08-31, under 510(k) number K221475.

Who is the listed applicant for MyClearALIGN Dental Aligner System?

The FDA 510(k) record lists Key Dental Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MyClearALIGN Dental Aligner System?

The FDA product code for MyClearALIGN Dental Aligner System is NXC.

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