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FDA 510(k)

OverCEM SA 開放式；OverCEM SA 透明式；OverCEM SA 不透明式；OverCEM Ti-牙根；OverCEM Cer-牙根

K 號：K242366 · 2025-01-10

申請人Overfibers S.R.L.
決定日期2025-01-10
產品代碼EMA
諮詢委員會DE
決定相當於

器材摘要

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Overfibers S.R.L.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K242366. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment?

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Overfibers S.R.L.. The 510(k) number is K242366.

When did OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment receive FDA 510(k) clearance?

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment received FDA 510(k) clearance on 2025-01-10, under 510(k) number K242366.

Who is the listed applicant for OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment?

The FDA 510(k) record lists Overfibers S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment?

The FDA product code for OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment is EMA.

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

相關器械（代碼：EMA）

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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