金字塔牙植體與假牙
K 號：K180859 · 2018-12-13
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器材摘要
PYRAMIDION Dental Implants and Prostheses is the device name listed in this FDA 510(k) record. The listed applicant is Dentack Implants, Ltd.. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K180859. 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 PYRAMIDION Dental Implants and Prostheses?
PYRAMIDION Dental Implants and Prostheses is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Dentack Implants, Ltd.. The 510(k) number is K180859.
When did PYRAMIDION Dental Implants and Prostheses receive FDA 510(k) clearance?
PYRAMIDION Dental Implants and Prostheses received FDA 510(k) clearance on 2018-12-13, under 510(k) number K180859.
Who is the listed applicant for PYRAMIDION Dental Implants and Prostheses?
The FDA 510(k) record lists Dentack Implants, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PYRAMIDION Dental Implants and Prostheses?
The FDA product code for PYRAMIDION Dental Implants and Prostheses is DZE.
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：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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