生物-C修復離子+
K 號：K201222 · 2021-02-11
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器材摘要
Bio-C Repair Ion+ is the device name listed in this FDA 510(k) record. The listed applicant is Angelus Industria DE Produtos Odontologicos S/A. It received FDA 510(k) clearance on 2021-02-11 under 510(k) number K201222. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Bio-C Repair Ion+?
Bio-C Repair Ion+ is a medical device that received FDA 510(k) clearance on 2021-02-11. The listed applicant is Angelus Industria DE Produtos Odontologicos S/A. The 510(k) number is K201222.
When did Bio-C Repair Ion+ receive FDA 510(k) clearance?
Bio-C Repair Ion+ received FDA 510(k) clearance on 2021-02-11, under 510(k) number K201222.
Who is the listed applicant for Bio-C Repair Ion+?
The FDA 510(k) record lists Angelus Industria DE Produtos Odontologicos S/A as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bio-C Repair Ion+?
The FDA product code for Bio-C Repair Ion+ is KIF.
相關臨床試驗
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其他以 Angelus Industria DE Produtos Odontologicos S/A 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：KIF）
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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