FDA 510(k)

Microdent Ektos Implant System

Número K: K153650 · 2016-05-20

Data da decisão2016-05-20

Código do produtoDZE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Microdent Ektos Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Implants Microdent System S.L. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K153650. 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 Microdent Ektos Implant System?

Microdent Ektos Implant System is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Implants Microdent System S.L. The 510(k) number is K153650.

When did Microdent Ektos Implant System receive FDA 510(k) clearance?

Microdent Ektos Implant System received FDA 510(k) clearance on 2016-05-20, under 510(k) number K153650.

Who is the listed applicant for Microdent Ektos Implant System?

The FDA 510(k) record lists Implants Microdent System S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microdent Ektos Implant System?

The FDA product code for Microdent Ektos Implant System is DZE.

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