FDA 510(k)

3D Predict

Número K: K200214 · 2020-02-24

Data da decisão2020-02-24

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

3D Predict is the device name listed in this FDA 510(k) record. The listed applicant is 3D Smile USA, Inc.. It received FDA 510(k) clearance on 2020-02-24 under 510(k) number K200214. 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 3D Predict?

3D Predict is a medical device that received FDA 510(k) clearance on 2020-02-24. The listed applicant is 3D Smile USA, Inc.. The 510(k) number is K200214.

When did 3D Predict receive FDA 510(k) clearance?

3D Predict received FDA 510(k) clearance on 2020-02-24, under 510(k) number K200214.

Who is the listed applicant for 3D Predict?

The FDA 510(k) record lists 3D Smile USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D Predict?

The FDA product code for 3D Predict is NXC.

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