SureCure 歸正牙套系統
K 號：K182329 · 2018-11-08
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器材摘要
SureCure Orthodontic Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is Digital Orthodontic Care. It received FDA 510(k) clearance on 2018-11-08 under 510(k) number K182329. 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 SureCure Orthodontic Aligner System?
SureCure Orthodontic Aligner System is a medical device that received FDA 510(k) clearance on 2018-11-08. The listed applicant is Digital Orthodontic Care. The 510(k) number is K182329.
When did SureCure Orthodontic Aligner System receive FDA 510(k) clearance?
SureCure Orthodontic Aligner System received FDA 510(k) clearance on 2018-11-08, under 510(k) number K182329.
Who is the listed applicant for SureCure Orthodontic Aligner System?
The FDA 510(k) record lists Digital Orthodontic Care as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SureCure Orthodontic Aligner System?
The FDA product code for SureCure Orthodontic Aligner System 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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