FDA 510(k)

BoniPlus Dental G-Mesh System

Número K: K182759 · 2020-07-29

RequerenteMontjade Engineering Co., Ltd.

Data da decisão2020-07-29

Código do produtoJEY

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

BoniPlus Dental G-Mesh System is the device name listed in this FDA 510(k) record. The listed applicant is Montjade Engineering Co., Ltd.. It received FDA 510(k) clearance on 2020-07-29 under 510(k) number K182759. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BoniPlus Dental G-Mesh System?

BoniPlus Dental G-Mesh System is a medical device that received FDA 510(k) clearance on 2020-07-29. The listed applicant is Montjade Engineering Co., Ltd.. The 510(k) number is K182759.

When did BoniPlus Dental G-Mesh System receive FDA 510(k) clearance?

BoniPlus Dental G-Mesh System received FDA 510(k) clearance on 2020-07-29, under 510(k) number K182759.

Who is the listed applicant for BoniPlus Dental G-Mesh System?

The FDA 510(k) record lists Montjade Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BoniPlus Dental G-Mesh System?

The FDA product code for BoniPlus Dental G-Mesh System is JEY.

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