DTX工作室輔助
K 號：K252086 · 2025-11-17
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器材摘要
DTX Studio Assist is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare C/O Medicim NV. It received FDA 510(k) clearance on 2025-11-17 under 510(k) number K252086. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DTX Studio Assist?
DTX Studio Assist is a medical device that received FDA 510(k) clearance on 2025-11-17. The listed applicant is Nobel Biocare C/O Medicim NV. The 510(k) number is K252086.
When did DTX Studio Assist receive FDA 510(k) clearance?
DTX Studio Assist received FDA 510(k) clearance on 2025-11-17, under 510(k) number K252086.
Who is the listed applicant for DTX Studio Assist?
The FDA 510(k) record lists Nobel Biocare C/O Medicim NV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DTX Studio Assist?
The FDA product code for DTX Studio Assist is MYN.
相關臨床試驗
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相關器械（代碼：MYN）
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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