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FDA 510(k)

BoniPlus Dental G-Mesh System

K-Number: K182759 · 2020-07-29

ApplicantMontjade Engineering Co., Ltd.
Decision Date2020-07-29
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Montjade Engineering Co., Ltd.. The 510(k) number is K182759.

When was BoniPlus Dental G-Mesh System approved by the FDA?

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

What company makes BoniPlus Dental G-Mesh System?

BoniPlus Dental G-Mesh System is manufactured by Montjade Engineering Co., Ltd..

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

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

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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