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FDA 510(k)

無顏色牙齒矽酸鎂及預著色牙齒矽酸鎂

K 號：K192535 · 2020-01-31

申請人Qinhuangdao Audental Metal Technology Co., Ltd.
決定日期2020-01-31
產品代碼EIH
諮詢委員會DE
決定相當於

器材摘要

Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia is the device name listed in this FDA 510(k) record. The listed applicant is Qinhuangdao Audental Metal Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-01-31 under 510(k) number K192535. 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 Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia?

Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia is a medical device that received FDA 510(k) clearance on 2020-01-31. The listed applicant is Qinhuangdao Audental Metal Technology Co., Ltd.. The 510(k) number is K192535.

When did Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia receive FDA 510(k) clearance?

Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia received FDA 510(k) clearance on 2020-01-31, under 510(k) number K192535.

Who is the listed applicant for Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia?

The FDA 510(k) record lists Qinhuangdao Audental Metal Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia?

The FDA product code for Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia is EIH.

相關臨床試驗

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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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