FDA 510(k)

牙醫瓷粉

K 號：K242400 · 2024-10-10

申請人Yilink (Tianjin) Biotechnology Co., Ltd.

決定日期2024-10-10

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Dental porcelain powder is the device name listed in this FDA 510(k) record. The listed applicant is Yilink (Tianjin) Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K242400. 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 Dental porcelain powder?

Dental porcelain powder is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is Yilink (Tianjin) Biotechnology Co., Ltd.. The 510(k) number is K242400.

When did Dental porcelain powder receive FDA 510(k) clearance?

Dental porcelain powder received FDA 510(k) clearance on 2024-10-10, under 510(k) number K242400.

Who is the listed applicant for Dental porcelain powder?

The FDA 510(k) record lists Yilink (Tianjin) Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental porcelain powder?

The FDA product code for Dental porcelain powder is EIH.

其他以 Yilink (Tianjin) Biotechnology Co., Ltd. 為申請人之記錄

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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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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