Z-CAD 微笑
K 號:K170050 · 2018-08-23
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器材摘要
Z-CAD smile is the device name listed in this FDA 510(k) record. The listed applicant is Metoxit AG. It received FDA 510(k) clearance on 2018-08-23 under 510(k) number K170050. 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 Z-CAD smile?
Z-CAD smile is a medical device that received FDA 510(k) clearance on 2018-08-23. The listed applicant is Metoxit AG. The 510(k) number is K170050.
When did Z-CAD smile receive FDA 510(k) clearance?
Z-CAD smile received FDA 510(k) clearance on 2018-08-23, under 510(k) number K170050.
Who is the listed applicant for Z-CAD smile?
The FDA 510(k) record lists Metoxit AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Z-CAD smile?
The FDA product code for Z-CAD smile is EIH.
相關臨床試驗
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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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