ARENA Star, Galaxy Star
K 號：K250063 · 2025-07-10
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器材摘要
ARENA Star, Galaxy Star is the device name listed in this FDA 510(k) record. The listed applicant is Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2025-07-10 under 510(k) number K250063. 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 ARENA Star, Galaxy Star?
ARENA Star, Galaxy Star is a medical device that received FDA 510(k) clearance on 2025-07-10. The listed applicant is Arum Dentistry Co., Ltd.. The 510(k) number is K250063.
When did ARENA Star, Galaxy Star receive FDA 510(k) clearance?
ARENA Star, Galaxy Star received FDA 510(k) clearance on 2025-07-10, under 510(k) number K250063.
Who is the listed applicant for ARENA Star, Galaxy Star?
The FDA 510(k) record lists Arum Dentistry Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ARENA Star, Galaxy Star?
The FDA product code for ARENA Star, Galaxy Star is EIH.
相關臨床試驗
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其他以 Arum Dentistry Co., Ltd. 為申請人之記錄
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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