BIJOU 歸正牙陶瓷托槽
K 號：K152167 · 2016-05-27
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器材摘要
BIJOU Orthodontic Ceramic Bracket is the device name listed in this FDA 510(k) record. The listed applicant is World Bio Tech Co., Ltd.. It received FDA 510(k) clearance on 2016-05-27 under 510(k) number K152167. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BIJOU Orthodontic Ceramic Bracket?
BIJOU Orthodontic Ceramic Bracket is a medical device that received FDA 510(k) clearance on 2016-05-27. The listed applicant is World Bio Tech Co., Ltd.. The 510(k) number is K152167.
When did BIJOU Orthodontic Ceramic Bracket receive FDA 510(k) clearance?
BIJOU Orthodontic Ceramic Bracket received FDA 510(k) clearance on 2016-05-27, under 510(k) number K152167.
Who is the listed applicant for BIJOU Orthodontic Ceramic Bracket?
The FDA 510(k) record lists World Bio Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BIJOU Orthodontic Ceramic Bracket?
The FDA product code for BIJOU Orthodontic Ceramic Bracket is NJM.
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：NJM）
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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