FDA 510(k)

鈦酸鹽牙科陶瓷

K 號：K214005 · 2022-02-18

申請人Shenzhen Yurucheng Dental Materials Co., Ltd.

決定日期2022-02-18

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Zirconia Dental Ceramics is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yurucheng Dental Materials Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K214005. 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 Zirconia Dental Ceramics?

Zirconia Dental Ceramics is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Shenzhen Yurucheng Dental Materials Co., Ltd.. The 510(k) number is K214005.

When did Zirconia Dental Ceramics receive FDA 510(k) clearance?

Zirconia Dental Ceramics received FDA 510(k) clearance on 2022-02-18, under 510(k) number K214005.

Who is the listed applicant for Zirconia Dental Ceramics?

The FDA 510(k) record lists Shenzhen Yurucheng Dental Materials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zirconia Dental Ceramics?

The FDA product code for Zirconia Dental Ceramics is EIH.

其他以 Shenzhen Yurucheng Dental Materials 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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