CELTRA Press
K 號：K161269 · 2016-08-12
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器材摘要
CELTRA Press is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2016-08-12 under 510(k) number K161269. 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 CELTRA Press?
CELTRA Press is a medical device that received FDA 510(k) clearance on 2016-08-12. The listed applicant is Dentsply Sirona. The 510(k) number is K161269.
When did CELTRA Press receive FDA 510(k) clearance?
CELTRA Press received FDA 510(k) clearance on 2016-08-12, under 510(k) number K161269.
Who is the listed applicant for CELTRA Press?
The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CELTRA Press?
The FDA product code for CELTRA Press is EIH.
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其他以 Dentsply Sirona 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：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。
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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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