純淨陶瓷植入物
K 號：K151328 · 2016-01-11
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器材摘要
PURE Ceramic Implants is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA. It received FDA 510(k) clearance on 2016-01-11 under 510(k) number K151328. 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 PURE Ceramic Implants?
PURE Ceramic Implants is a medical device that received FDA 510(k) clearance on 2016-01-11. The listed applicant is Straumann USA. The 510(k) number is K151328.
When did PURE Ceramic Implants receive FDA 510(k) clearance?
PURE Ceramic Implants received FDA 510(k) clearance on 2016-01-11, under 510(k) number K151328.
Who is the listed applicant for PURE Ceramic Implants?
The FDA 510(k) record lists Straumann USA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PURE Ceramic Implants?
The FDA product code for PURE Ceramic 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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