鈦酸鹽牙科陶瓷
K 號：K170894 · 2017-08-01
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器材摘要
Zirconia Dental Ceramics is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Besmile Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K170894. 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 2017-08-01. The listed applicant is Chengdu Besmile Biotechnology Co., Ltd.. The 510(k) number is K170894.
When did Zirconia Dental Ceramics receive FDA 510(k) clearance?
Zirconia Dental Ceramics received FDA 510(k) clearance on 2017-08-01, under 510(k) number K170894.
Who is the listed applicant for Zirconia Dental Ceramics?
The FDA 510(k) record lists Chengdu Besmile Biotechnology 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.
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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