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FDA 510(k)

CreoDent Solidex 訂製牙根台

K 號：K162734 · 2017-05-08

申請人Creodent Prosthetics, Ltd.
決定日期2017-05-08
產品代碼NHA
諮詢委員會DE
決定相當於

器材摘要

CreoDent Solidex Customized Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Creodent Prosthetics, Ltd.. It received FDA 510(k) clearance on 2017-05-08 under 510(k) number K162734. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CreoDent Solidex Customized Abutment?

CreoDent Solidex Customized Abutment is a medical device that received FDA 510(k) clearance on 2017-05-08. The listed applicant is Creodent Prosthetics, Ltd.. The 510(k) number is K162734.

When did CreoDent Solidex Customized Abutment receive FDA 510(k) clearance?

CreoDent Solidex Customized Abutment received FDA 510(k) clearance on 2017-05-08, under 510(k) number K162734.

Who is the listed applicant for CreoDent Solidex Customized Abutment?

The FDA 510(k) record lists Creodent Prosthetics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CreoDent Solidex Customized Abutment?

The FDA product code for CreoDent Solidex Customized Abutment is NHA.

相關臨床試驗

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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 Creodent Prosthetics, 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。

K220390CreoDent Solidex 訂製牙根台及螺釘K211427CREOKORREKT 調節器K202909CreoDent Solidex 訂製牙根台K202095CreoDent Solidex 訂製牙根台及螺釘K170100CreoDent Solidex 訂製牙根台及螺釘K160436CreoDent Solidex 訂製牙根台

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相關器械（代碼：NHA）

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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