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FDA 510(k)

NobelProcera HT ML FCZ Implant Bridge and Framework

K 號：K160158 · 2016-07-25

申請人Nobel Biocare AB
決定日期2016-07-25
產品代碼NHA
諮詢委員會DE
決定Substantially Equivalent

器材摘要

NobelProcera HT ML FCZ Implant Bridge and Framework 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 2016-07-25 under 510(k) number K160158. 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 NobelProcera HT ML FCZ Implant Bridge and Framework?

NobelProcera HT ML FCZ Implant Bridge and Framework is a medical device that received FDA 510(k) clearance on 2016-07-25. The listed applicant is Nobel Biocare AB. The 510(k) number is K160158.

When did NobelProcera HT ML FCZ Implant Bridge and Framework receive FDA 510(k) clearance?

NobelProcera HT ML FCZ Implant Bridge and Framework received FDA 510(k) clearance on 2016-07-25, under 510(k) number K160158.

Who is the listed applicant for NobelProcera HT ML FCZ Implant Bridge and Framework?

The FDA 510(k) record lists Nobel Biocare AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NobelProcera HT ML FCZ Implant Bridge and Framework?

The FDA product code for NobelProcera HT ML FCZ Implant Bridge and Framework is NHA.

相關臨床試驗

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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。

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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。

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.

官方來源

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