伊藤羅 lumina™ Pro
K 號：K240573 · 2024-08-16
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器材摘要
iTero Lumina™ Pro is the device name listed in this FDA 510(k) record. The listed applicant is Align Technology , Ltd.. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K240573. The device is classified under product code NTK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the iTero Lumina™ Pro?
iTero Lumina™ Pro is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is Align Technology , Ltd.. The 510(k) number is K240573.
When did iTero Lumina™ Pro receive FDA 510(k) clearance?
iTero Lumina™ Pro received FDA 510(k) clearance on 2024-08-16, under 510(k) number K240573.
Who is the listed applicant for iTero Lumina™ Pro?
The FDA 510(k) record lists Align Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iTero Lumina™ Pro?
The FDA product code for iTero Lumina™ Pro is NTK.
相關臨床試驗
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其他以 Align Technology , Ltd. 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：NTK）
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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