BLT 齿植系統
K 號：K212364 · 2022-08-10
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器材摘要
BLT Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Bio Concept Co., Ltd.. It received FDA 510(k) clearance on 2022-08-10 under 510(k) number K212364. 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 BLT Dental Implant System?
BLT Dental Implant System is a medical device that received FDA 510(k) clearance on 2022-08-10. The listed applicant is Bio Concept Co., Ltd.. The 510(k) number is K212364.
When did BLT Dental Implant System receive FDA 510(k) clearance?
BLT Dental Implant System received FDA 510(k) clearance on 2022-08-10, under 510(k) number K212364.
Who is the listed applicant for BLT Dental Implant System?
The FDA 510(k) record lists Bio Concept Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BLT Dental Implant System?
The FDA product code for BLT Dental Implant System is DZE.
相關臨床試驗
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其他以 Bio Concept Co., Ltd. 為申請人之記錄
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。
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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