EthanZir 鑫鎂
K 號：K191304 · 2019-11-04
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器材摘要
EthanZir Zirconia is the device name listed in this FDA 510(k) record. The listed applicant is Besorah Dental Solutions NZ Limited. It received FDA 510(k) clearance on 2019-11-04 under 510(k) number K191304. 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 EthanZir Zirconia?
EthanZir Zirconia is a medical device that received FDA 510(k) clearance on 2019-11-04. The listed applicant is Besorah Dental Solutions NZ Limited. The 510(k) number is K191304.
When did EthanZir Zirconia receive FDA 510(k) clearance?
EthanZir Zirconia received FDA 510(k) clearance on 2019-11-04, under 510(k) number K191304.
Who is the listed applicant for EthanZir Zirconia?
The FDA 510(k) record lists Besorah Dental Solutions NZ Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EthanZir Zirconia?
The FDA product code for EthanZir 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。
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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