FDA 510(k)

迪亞菲爾 & 迪亞菲爾膠囊

K 號：K210421 · 2021-06-28

決定日期2021-06-28

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Diafil & Diafil Capsule 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 2021-06-28 under 510(k) number K210421. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diafil & Diafil Capsule?

Diafil & Diafil Capsule is a medical device that received FDA 510(k) clearance on 2021-06-28. The listed applicant is DiaDent Group International. The 510(k) number is K210421.

When did Diafil & Diafil Capsule receive FDA 510(k) clearance?

Diafil & Diafil Capsule received FDA 510(k) clearance on 2021-06-28, under 510(k) number K210421.

Who is the listed applicant for Diafil & Diafil Capsule?

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 Diafil & Diafil Capsule?

The FDA product code for Diafil & Diafil Capsule is EBF.

其他以 DiaDent Group International 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。

K254152Dia-X Sil Light Body K254142Dia-X Sil Heavy Body K261166DIA-CEM K261093DIAFIL K261071DIAFIL 大量流量（經濟包裝）；DIAFIL 大量流量（補充包裝）；DIAFIL 大量流量（0.5g）K254112迪亞-X 靜脈針

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相關器械（代碼：EBF）

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。

K262982Core·it雙用式醫療設備規範文本Spident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695流動性修復材質（KP-Flow LF，KP-Flow MF，KP-Flow HF）Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus 填充劑；Tetric plus 流動劑Ivoclar Vivadent, Inc.K262228超越大量填充濃縮複合材料Ultradent Products, Inc.K261246SRGC-06GC America, Inc.

官方來源

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