FDA 510(k)

TopCEM-Try 薄層試戴膠

K 號：K242572 · 2024-12-20

申請人Rizhao Huge Biomaterials Company, Ltd.

決定日期2024-12-20

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

TopCEM-Try in Veneer Try-in Gel 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 2024-12-20 under 510(k) number K242572. 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 TopCEM-Try in Veneer Try-in Gel?

TopCEM-Try in Veneer Try-in Gel is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K242572.

When did TopCEM-Try in Veneer Try-in Gel receive FDA 510(k) clearance?

TopCEM-Try in Veneer Try-in Gel received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242572.

Who is the listed applicant for TopCEM-Try in Veneer Try-in Gel?

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 TopCEM-Try in Veneer Try-in Gel?

The FDA product code for TopCEM-Try in Veneer Try-in Gel 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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