BoniPlus牙科G-Mesh系统
K号: K182759 · 2020-07-29
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决定日期2020-07-29
产品代码JEY
咨询委员会DE
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器械摘要
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.
常见问题
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.
相关临床试验
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相关器械（代码：JEY）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
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