正畸設備
K 號：K181747 · 2019-04-18
廣告
器材摘要
Orthodontic Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2019-04-18 under 510(k) number K181747. 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 Orthodontic Appliance?
Orthodontic Appliance is a medical device that received FDA 510(k) clearance on 2019-04-18. The listed applicant is Shandong Huge Dental Material Corporation. The 510(k) number is K181747.
When did Orthodontic Appliance receive FDA 510(k) clearance?
Orthodontic Appliance received FDA 510(k) clearance on 2019-04-18, under 510(k) number K181747.
Who is the listed applicant for Orthodontic Appliance?
The FDA 510(k) record lists Shandong Huge Dental Material Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Orthodontic Appliance?
The FDA product code for Orthodontic Appliance 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。
其他以 Shandong Huge Dental Material Corporation 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：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。
廣告