牙醫生技生物解離植體
K 號：K161281 · 2017-01-11
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器材摘要
Dentalis Bio Solution Implants is the device name listed in this FDA 510(k) record. The listed applicant is Dentalis Bio Solution Implants, LLC. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K161281. 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 Dentalis Bio Solution Implants?
Dentalis Bio Solution Implants is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Dentalis Bio Solution Implants, LLC. The 510(k) number is K161281.
When did Dentalis Bio Solution Implants receive FDA 510(k) clearance?
Dentalis Bio Solution Implants received FDA 510(k) clearance on 2017-01-11, under 510(k) number K161281.
Who is the listed applicant for Dentalis Bio Solution Implants?
The FDA 510(k) record lists Dentalis Bio Solution Implants, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dentalis Bio Solution Implants?
The FDA product code for Dentalis Bio Solution Implants is DZE.
相關臨床試驗
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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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