UNIQA 齿科植體系統
K 號：K180598 · 2018-08-08
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器材摘要
UNIQA Dental Implants System is the device name listed in this FDA 510(k) record. The listed applicant is Uniqa Dental, Ltd.. It received FDA 510(k) clearance on 2018-08-08 under 510(k) number K180598. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the UNIQA Dental Implants System?
UNIQA Dental Implants System is a medical device that received FDA 510(k) clearance on 2018-08-08. The listed applicant is Uniqa Dental, Ltd.. The 510(k) number is K180598.
When did UNIQA Dental Implants System receive FDA 510(k) clearance?
UNIQA Dental Implants System received FDA 510(k) clearance on 2018-08-08, under 510(k) number K180598.
Who is the listed applicant for UNIQA Dental Implants System?
The FDA 510(k) record lists Uniqa Dental, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UNIQA Dental Implants System?
The FDA product code for UNIQA Dental Implants System is DZE.
相關臨床試驗
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其他以 Uniqa Dental, 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。
相關器械（代碼：DZE）
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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