FDA 510(k)

Sistema de Implantes Dentários MSDI

Número K: K191443 · 2020-06-26

RequerenteMedical Systems and Devices International , Ltd.

Data da decisão2020-06-26

Código do produtoDZE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

MSDI Dental Implants System is the device name listed in this FDA 510(k) record. The listed applicant is Medical Systems and Devices International , Ltd.. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K191443. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MSDI Dental Implants System?

MSDI Dental Implants System is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Medical Systems and Devices International , Ltd.. The 510(k) number is K191443.

When did MSDI Dental Implants System receive FDA 510(k) clearance?

MSDI Dental Implants System received FDA 510(k) clearance on 2020-06-26, under 510(k) number K191443.

Who is the listed applicant for MSDI Dental Implants System?

The FDA 510(k) record lists Medical Systems and Devices International , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MSDI Dental Implants System?

The FDA product code for MSDI Dental Implants System is DZE.

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Fonte oficial

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