赫利奧斯密封F+
K 號：K190339 · 2019-07-29
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器材摘要
Helioseal F Plus is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2019-07-29 under 510(k) number K190339. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Helioseal F Plus?
Helioseal F Plus is a medical device that received FDA 510(k) clearance on 2019-07-29. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K190339.
When did Helioseal F Plus receive FDA 510(k) clearance?
Helioseal F Plus received FDA 510(k) clearance on 2019-07-29, under 510(k) number K190339.
Who is the listed applicant for Helioseal F Plus?
The FDA 510(k) record lists Ivoclar Vivadent, AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Helioseal F Plus?
The FDA product code for Helioseal F Plus is EBC.
相關臨床試驗
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其他以 Ivoclar Vivadent, AG 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：EBC）
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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