CEREC 快速噴釉
K 號：K160099 · 2016-06-02
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器材摘要
CEREC SpeedGlaze is the device name listed in this FDA 510(k) record. The listed applicant is Sirona Dental Systems GmbH. It received FDA 510(k) clearance on 2016-06-02 under 510(k) number K160099. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CEREC SpeedGlaze?
CEREC SpeedGlaze is a medical device that received FDA 510(k) clearance on 2016-06-02. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K160099.
When did CEREC SpeedGlaze receive FDA 510(k) clearance?
CEREC SpeedGlaze received FDA 510(k) clearance on 2016-06-02, under 510(k) number K160099.
Who is the listed applicant for CEREC SpeedGlaze?
The FDA 510(k) record lists Sirona Dental Systems GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CEREC SpeedGlaze?
The FDA product code for CEREC SpeedGlaze is EIH.
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。
相關器械（代碼：EIH）
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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