牙科鈣鋇矽酸鹽玻璃陶瓷
K 號：K230487 · 2023-07-03
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器材摘要
Dental Lithium Disilicate Glass-Ceramic is the device name listed in this FDA 510(k) record. The listed applicant is Fuzhou Rick Brown Biomaterials Co., Ltd.. It received FDA 510(k) clearance on 2023-07-03 under 510(k) number K230487. 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 Lithium Disilicate Glass-Ceramic?
Dental Lithium Disilicate Glass-Ceramic is a medical device that received FDA 510(k) clearance on 2023-07-03. The listed applicant is Fuzhou Rick Brown Biomaterials Co., Ltd.. The 510(k) number is K230487.
When did Dental Lithium Disilicate Glass-Ceramic receive FDA 510(k) clearance?
Dental Lithium Disilicate Glass-Ceramic received FDA 510(k) clearance on 2023-07-03, under 510(k) number K230487.
Who is the listed applicant for Dental Lithium Disilicate Glass-Ceramic?
The FDA 510(k) record lists Fuzhou Rick Brown Biomaterials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dental Lithium Disilicate Glass-Ceramic?
The FDA product code for Dental Lithium Disilicate Glass-Ceramic 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。
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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