FDA 510(k)

Biomate Dental Implant System

Número K: K170732 · 2018-10-26

RequerenteBiomate Medical Devices Technology Co., Ltd.

Data da decisão2018-10-26

Código do produtoDZE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Biomate Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Biomate Medical Devices Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-10-26 under 510(k) number K170732. 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 Biomate Dental Implant System?

Biomate Dental Implant System is a medical device that received FDA 510(k) clearance on 2018-10-26. The listed applicant is Biomate Medical Devices Technology Co., Ltd.. The 510(k) number is K170732.

When did Biomate Dental Implant System receive FDA 510(k) clearance?

Biomate Dental Implant System received FDA 510(k) clearance on 2018-10-26, under 510(k) number K170732.

Who is the listed applicant for Biomate Dental Implant System?

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

What is the FDA product code for Biomate Dental Implant System?

The FDA product code for Biomate Dental Implant System is DZE.

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