DIA-CEM
K 號：K261166 · 2026-07-09
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器材摘要
DIA-CEM is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2026-07-09 under 510(k) number K261166. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DIA-CEM?
DIA-CEM is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is DiaDent Group International. The 510(k) number is K261166.
When did DIA-CEM receive FDA 510(k) clearance?
DIA-CEM received FDA 510(k) clearance on 2026-07-09, under 510(k) number K261166.
Who is the listed applicant for DIA-CEM?
FDA 510(k) 記錄將 DiaDent Group International 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for DIA-CEM?
The FDA product code for DIA-CEM is EMA.
其他以 DiaDent Group International 為申請人之記錄
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相關器械（代碼：EMA）
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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