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FDA 510(k)

尼西恩牙醫氧化鋁陶瓷空白 & 牙醫氧化鋁陶瓷預上色空白

K 號：K160367 · 2016-07-27

申請人Nissin-Metec China Co., Ltd.
決定日期2016-07-27
產品代碼EIH
諮詢委員會DE
決定相當於

器材摘要

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Nissin-Metec China Co., Ltd.. It received FDA 510(k) clearance on 2016-07-27 under 510(k) number K160367. 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 Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is Nissin-Metec China Co., Ltd.. The 510(k) number is K160367.

When did Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank receive FDA 510(k) clearance?

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2016-07-27, under 510(k) number K160367.

Who is the listed applicant for Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA 510(k) record lists Nissin-Metec China Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA product code for Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is EIH.

相關臨床試驗

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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