FDA 510(k)

諾貝爾設計軟體

K 號：K153036 · 2016-06-02

決定日期2016-06-02

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

NobelDesign Software is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2016-06-02 under 510(k) number K153036. 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 NobelDesign Software?

NobelDesign Software is a medical device that received FDA 510(k) clearance on 2016-06-02. The listed applicant is Nobel Biocare AB. The 510(k) number is K153036.

When did NobelDesign Software receive FDA 510(k) clearance?

NobelDesign Software received FDA 510(k) clearance on 2016-06-02, under 510(k) number K153036.

Who is the listed applicant for NobelDesign Software?

FDA 510(k) 記錄將 Nobel Biocare AB 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for NobelDesign Software?

The FDA product code for NobelDesign Software is NHA.

其他以 Nobel Biocare AB 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。

K253988LiteSet 盤子 K253999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 K252197諾貝爾生物醫療 S 系列植入體 K243834諾貝爾齊哥馬TiUltra植入系統 K240346諾貝爾普雷塞拉矽酸鋁植入橋 K233208諾貝爾普雷塞拉钛金 ASC 牙根擴張器，奧米格里普臨床螺釘钛金

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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。

K262207固定式加長基座Unidental Co., Ltd.K260940貝拉特克條ZimVie US Corp, LLC K253999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 AB K261147Neodent植牙系統 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061生物地平線 CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

官方來源

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