FDA 510(k)

Dental Image Plate Scanner, Model DFC-4T-SMART

Número K: K214091 · 2022-03-02

RequerenteHefei Dentafilm Medical Equipment Co., Ltd.

Data da decisão2022-03-02

Código do produtoMUH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Image Plate Scanner, Model DFC-4T-SMART is the device name listed in this FDA 510(k) record. The listed applicant is Hefei Dentafilm Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K214091. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dental Image Plate Scanner, Model DFC-4T-SMART?

Dental Image Plate Scanner, Model DFC-4T-SMART is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Hefei Dentafilm Medical Equipment Co., Ltd.. The 510(k) number is K214091.

When did Dental Image Plate Scanner, Model DFC-4T-SMART receive FDA 510(k) clearance?

Dental Image Plate Scanner, Model DFC-4T-SMART received FDA 510(k) clearance on 2022-03-02, under 510(k) number K214091.

Who is the listed applicant for Dental Image Plate Scanner, Model DFC-4T-SMART?

The FDA 510(k) record lists Hefei Dentafilm Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Image Plate Scanner, Model DFC-4T-SMART?

The FDA product code for Dental Image Plate Scanner, Model DFC-4T-SMART is MUH.

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