FDA 510(k)

Endoform 牙科膠膜

K 號：K231305 · 2024-01-23

決定日期2024-01-23

產品代碼NPL

諮詢委員會DE

決定相當於

器材摘要

Endoform Dental Membrane is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2024-01-23 under 510(k) number K231305. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endoform Dental Membrane?

Endoform Dental Membrane is a medical device that received FDA 510(k) clearance on 2024-01-23. The listed applicant is Aroa Biosurgery , Ltd.. The 510(k) number is K231305.

When did Endoform Dental Membrane receive FDA 510(k) clearance?

Endoform Dental Membrane received FDA 510(k) clearance on 2024-01-23, under 510(k) number K231305.

Who is the listed applicant for Endoform Dental Membrane?

The FDA 510(k) record lists Aroa Biosurgery , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endoform Dental Membrane?

The FDA product code for Endoform Dental Membrane is NPL.

其他以 Aroa Biosurgery , Ltd. 為申請人之記錄

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相關器械（代碼：NPL）

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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