BoniPlus 齿科 G-Mesh 系統
K 號：K182759 · 2020-07-29
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器材摘要
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.
常見問題
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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相關器械（代碼：JEY）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
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