iTero Element 5D
K 號：K193659 · 2020-03-20
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器材摘要
iTero Element 5D is the device name listed in this FDA 510(k) record. The listed applicant is Align Technology, Inc.. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K193659. 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 Element 5D?
iTero Element 5D is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Align Technology, Inc.. The 510(k) number is K193659.
When did iTero Element 5D receive FDA 510(k) clearance?
iTero Element 5D received FDA 510(k) clearance on 2020-03-20, under 510(k) number K193659.
Who is the listed applicant for iTero Element 5D?
The FDA 510(k) record lists Align Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iTero Element 5D?
The FDA product code for iTero Element 5D is NTK.
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其他以 Align Technology, Inc. 為申請人之記錄
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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。
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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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