CompleClear 塑膠正畸牙套及牙線設備
K 號：K150830 · 2016-08-26
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器材摘要
CompleClear Plastic Orthodontic Bracket and Wire Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Oracrew. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K150830. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CompleClear Plastic Orthodontic Bracket and Wire Appliance?
CompleClear Plastic Orthodontic Bracket and Wire Appliance is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Oracrew. The 510(k) number is K150830.
When did CompleClear Plastic Orthodontic Bracket and Wire Appliance receive FDA 510(k) clearance?
CompleClear Plastic Orthodontic Bracket and Wire Appliance received FDA 510(k) clearance on 2016-08-26, under 510(k) number K150830.
Who is the listed applicant for CompleClear Plastic Orthodontic Bracket and Wire Appliance?
The FDA 510(k) record lists Oracrew as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CompleClear Plastic Orthodontic Bracket and Wire Appliance?
The FDA product code for CompleClear Plastic Orthodontic Bracket and Wire Appliance is DYW.
相關臨床試驗
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相關器械（代碼：DYW）
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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