FDA 510(k)

DIAFIL

K 號：K261093 · 2026-06-02

決定日期2026-06-02

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

DIAFIL 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 2026-06-02 under 510(k) number K261093. 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 is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is DiaDent Group International. The 510(k) number is K261093.

When did DIAFIL receive FDA 510(k) clearance?

DIAFIL received FDA 510(k) clearance on 2026-06-02, under 510(k) number K261093.

Who is the listed applicant for DIAFIL?

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?

The FDA product code for DIAFIL 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。

K254142Dia-X Sil Heavy Body K254152Dia-X Sil Light Body K261166DIA-CEM 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 K231552迪亞-塞姆

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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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