蛀牙檢測產品，含藥物或生物製劑
PMA 核准號：P170029 · 2025-03-03
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器材摘要
Caries detection product with drug or biologic is the device name listed in this FDA 510(k) record. The listed applicant is Calcivis Limited. It received FDA 510(k) clearance on 2025-03-03. The device is classified under product code QJX. It was reviewed by the DE advisory panel.
常見問題
What is the Caries detection product with drug or biologic?
Caries detection product with drug or biologic is a medical device that received FDA 510(k) clearance on 2025-03-03. The listed applicant is Calcivis Limited.
When did Caries detection product with drug or biologic receive FDA 510(k) clearance?
The clearance date for Caries detection product with drug or biologic can be found in the official FDA records.
Who is the listed applicant for Caries detection product with drug or biologic?
The FDA 510(k) record lists Calcivis Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Caries detection product with drug or biologic?
The FDA product code for Caries detection product with drug or biologic is QJX.
相關臨床試驗
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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