FDA 510(k)

SmileSeries

Número K: K221097 · 2022-07-14

RequerenteOrdont Orthodontic Laboratories, Inc.

Data da decisão2022-07-14

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

SmileSeries is the device name listed in this FDA 510(k) record. The listed applicant is Ordont Orthodontic Laboratories, Inc.. It received FDA 510(k) clearance on 2022-07-14 under 510(k) number K221097. 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 SmileSeries?

SmileSeries is a medical device that received FDA 510(k) clearance on 2022-07-14. The listed applicant is Ordont Orthodontic Laboratories, Inc.. The 510(k) number is K221097.

When did SmileSeries receive FDA 510(k) clearance?

SmileSeries received FDA 510(k) clearance on 2022-07-14, under 510(k) number K221097.

Who is the listed applicant for SmileSeries?

The FDA 510(k) record lists Ordont Orthodontic Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmileSeries?

The FDA product code for SmileSeries is NXC.

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Fonte oficial

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