免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

CreoDent Solidex 訂製牙根台

K 號：K202909 · 2021-04-02

申請人Creodent Prosthetics, Ltd.
決定日期2021-04-02
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 2021-04-02 under 510(k) number K202909. 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 2021-04-02. The listed applicant is Creodent Prosthetics, Ltd.. The 510(k) number is K202909.

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

CreoDent Solidex Customized Abutment received FDA 510(k) clearance on 2021-04-02, under 510(k) number K202909.

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

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 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K202095CreoDent Solidex 訂製牙根台及螺釘K170100CreoDent Solidex 訂製牙根台及螺釘K162734CreoDent Solidex 訂製牙根台K160436CreoDent Solidex 訂製牙根台

查看所有 7 項裝置 →

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。

K262207固定式加長基座Unidental Co., Ltd.K260940貝拉特克條ZimVie US Corp, LLCK253999通用基座 ASC 接合；通用基座 ASC 非接合；通用基座 MUA ASC；臨時基座 接合和非接合；恢復基座 極锥連接；Omnigrip臨床螺釘 鈦金；Omnigrip假牙螺釘Nobel Biocare ABK261147Neodent植牙系統 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061生物地平線 CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

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。

↑