FDA 510(k)

DenMat 大塊填充複合材

K 號：K242097 · 2024-10-15

決定日期2024-10-15

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

DenMat Bulk Fill Composite is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Holdings, LLC. It received FDA 510(k) clearance on 2024-10-15 under 510(k) number K242097. 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 DenMat Bulk Fill Composite?

DenMat Bulk Fill Composite is a medical device that received FDA 510(k) clearance on 2024-10-15. The listed applicant is Den-Mat Holdings, LLC. The 510(k) number is K242097.

When did DenMat Bulk Fill Composite receive FDA 510(k) clearance?

DenMat Bulk Fill Composite received FDA 510(k) clearance on 2024-10-15, under 510(k) number K242097.

Who is the listed applicant for DenMat Bulk Fill Composite?

FDA 510(k) 記錄將 Den-Mat Holdings, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for DenMat Bulk Fill Composite?

The FDA product code for DenMat Bulk Fill Composite is EBF.

其他以 Den-Mat Holdings, LLC 為申請人之記錄

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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。

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官方來源

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