3D預測
K 號：K200214 · 2020-02-24
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器材摘要
3D Predict is the device name listed in this FDA 510(k) record. The listed applicant is 3D Smile USA, Inc.. It received FDA 510(k) clearance on 2020-02-24 under 510(k) number K200214. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the 3D Predict?
3D Predict is a medical device that received FDA 510(k) clearance on 2020-02-24. The listed applicant is 3D Smile USA, Inc.. The 510(k) number is K200214.
When did 3D Predict receive FDA 510(k) clearance?
3D Predict received FDA 510(k) clearance on 2020-02-24, under 510(k) number K200214.
Who is the listed applicant for 3D Predict?
The FDA 510(k) record lists 3D Smile USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 3D Predict?
The FDA product code for 3D Predict is NXC.
相關臨床試驗
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相關器械（代碼：NXC）
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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