FDA 510(k)

DenMat 多層氧化鋁礦碟

K 號：K251593 · 2025-08-25

決定日期2025-08-25

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

DenMat Multilayered Zirconia Disc is the device name listed in this FDA 510(k) record. The listed applicant is Denmat Holding, LLC. It received FDA 510(k) clearance on 2025-08-25 under 510(k) number K251593. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DenMat Multilayered Zirconia Disc?

DenMat Multilayered Zirconia Disc is a medical device that received FDA 510(k) clearance on 2025-08-25. The listed applicant is Denmat Holding, LLC. The 510(k) number is K251593.

When did DenMat Multilayered Zirconia Disc receive FDA 510(k) clearance?

DenMat Multilayered Zirconia Disc received FDA 510(k) clearance on 2025-08-25, under 510(k) number K251593.

Who is the listed applicant for DenMat Multilayered Zirconia Disc?

The FDA 510(k) record lists Denmat Holding, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DenMat Multilayered Zirconia Disc?

The FDA product code for DenMat Multilayered Zirconia Disc is EIH.

其他以 Denmat Holding, LLC 為申請人之記錄

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K222357DenMat 輔酶醛去敏劑

相關器械（代碼：EIH）

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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