ALFA GATE 齒齒植體系統
K 號：K182143 · 2019-10-03
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器材摘要
ALFA GATE Dental Implants System is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Gate Mazen, Ltd.. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K182143. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ALFA GATE Dental Implants System?
ALFA GATE Dental Implants System is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is Alfa Gate Mazen, Ltd.. The 510(k) number is K182143.
When did ALFA GATE Dental Implants System receive FDA 510(k) clearance?
ALFA GATE Dental Implants System received FDA 510(k) clearance on 2019-10-03, under 510(k) number K182143.
Who is the listed applicant for ALFA GATE Dental Implants System?
The FDA 510(k) record lists Alfa Gate Mazen, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ALFA GATE Dental Implants System?
The FDA product code for ALFA GATE Dental Implants System is DZE.
相關臨床試驗
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相關器械（代碼：DZE）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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