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FDA 510(k)

附加製造（光固化）牙冠橋樑膠

K 號：K250497 · 2025-04-30

申請人Aidite (Qinhuangdao) Technology Co., Ltd.
決定日期2025-04-30
產品代碼EBF
諮詢委員會DE
決定相當於

器材摘要

Additive Manufacturing (Light Curing) Crown Bridge Resin is the device name listed in this FDA 510(k) record. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-30 under 510(k) number K250497. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Additive Manufacturing (Light Curing) Crown Bridge Resin?

Additive Manufacturing (Light Curing) Crown Bridge Resin is a medical device that received FDA 510(k) clearance on 2025-04-30. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K250497.

When did Additive Manufacturing (Light Curing) Crown Bridge Resin receive FDA 510(k) clearance?

Additive Manufacturing (Light Curing) Crown Bridge Resin received FDA 510(k) clearance on 2025-04-30, under 510(k) number K250497.

Who is the listed applicant for Additive Manufacturing (Light Curing) Crown Bridge Resin?

The FDA 510(k) record lists Aidite (Qinhuangdao) Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Additive Manufacturing (Light Curing) Crown Bridge Resin?

The FDA product code for Additive Manufacturing (Light Curing) Crown Bridge Resin is EBF.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Aidite (Qinhuangdao) Technology 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。

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相關器械（代碼：EBF）

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。

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官方來源

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