Shaders ZR
K 號：K190569 · 2019-07-29
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器材摘要
Shaders ZR is the device name listed in this FDA 510(k) record. The listed applicant is Digital Age Dental Lab. It received FDA 510(k) clearance on 2019-07-29 under 510(k) number K190569. 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 Shaders ZR?
Shaders ZR is a medical device that received FDA 510(k) clearance on 2019-07-29. The listed applicant is Digital Age Dental Lab. The 510(k) number is K190569.
When did Shaders ZR receive FDA 510(k) clearance?
Shaders ZR received FDA 510(k) clearance on 2019-07-29, under 510(k) number K190569.
Who is the listed applicant for Shaders ZR?
The FDA 510(k) record lists Digital Age Dental Lab as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Shaders ZR?
The FDA product code for Shaders ZR is EIH.
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：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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