DX. Bond V 齿科粘合劑
K 號：K232978 · 2023-09-22
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器材摘要
DX. Bond V Dental Bonding Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Sino-Dentex Co., Ltd.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K232978. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DX. Bond V Dental Bonding Adhesive?
DX. Bond V Dental Bonding Adhesive is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Sino-Dentex Co., Ltd.. The 510(k) number is K232978.
When did DX. Bond V Dental Bonding Adhesive receive FDA 510(k) clearance?
DX. Bond V Dental Bonding Adhesive received FDA 510(k) clearance on 2023-09-22, under 510(k) number K232978.
Who is the listed applicant for DX. Bond V Dental Bonding Adhesive?
The FDA 510(k) record lists Sino-Dentex Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DX. Bond V Dental Bonding Adhesive?
The FDA product code for DX. Bond V Dental Bonding Adhesive is KLE.
相關臨床試驗
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相關器械（代碼：KLE）
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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