藍光相PowerCure
K 號：K190272 · 2019-07-03
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器材摘要
Bluephase PowerCure 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 2019-07-03 under 510(k) number K190272. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Bluephase PowerCure?
Bluephase PowerCure is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K190272.
When did Bluephase PowerCure receive FDA 510(k) clearance?
Bluephase PowerCure received FDA 510(k) clearance on 2019-07-03, under 510(k) number K190272.
Who is the listed applicant for Bluephase PowerCure?
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 Bluephase PowerCure?
The FDA product code for Bluephase PowerCure is EBZ.
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其他以 Ivoclar Vivadent, AG 為申請人之記錄
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相關器械（代碼：EBZ）
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
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