U-對齊器
K 號：K191308 · 2020-04-23
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器材摘要
U-Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Universal Orthodontic Laboratory, Inc.. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K191308. 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 U-Aligner?
U-Aligner is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Universal Orthodontic Laboratory, Inc.. The 510(k) number is K191308.
When did U-Aligner receive FDA 510(k) clearance?
U-Aligner received FDA 510(k) clearance on 2020-04-23, under 510(k) number K191308.
Who is the listed applicant for U-Aligner?
The FDA 510(k) record lists Universal Orthodontic Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for U-Aligner?
The FDA product code for U-Aligner is NXC.
相關臨床試驗
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：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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