FDA 510(k)

TrusFIL大眾複合修復材料

K 號：K202063 · 2021-10-06

申請人Rizhao Huge Biomaterials Company, Ltd.

決定日期2021-10-06

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

TrusFIL Universal Composite Restorative is the device name listed in this FDA 510(k) record. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2021-10-06 under 510(k) number K202063. 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 TrusFIL Universal Composite Restorative?

TrusFIL Universal Composite Restorative is a medical device that received FDA 510(k) clearance on 2021-10-06. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K202063.

When did TrusFIL Universal Composite Restorative receive FDA 510(k) clearance?

TrusFIL Universal Composite Restorative received FDA 510(k) clearance on 2021-10-06, under 510(k) number K202063.

Who is the listed applicant for TrusFIL Universal Composite Restorative?

The FDA 510(k) record lists Rizhao Huge Biomaterials Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TrusFIL Universal Composite Restorative?

The FDA product code for TrusFIL Universal Composite Restorative is EBF.

其他以 Rizhao Huge Biomaterials Company, Ltd. 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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