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FDA 510(k)

Neodent Implant System - Titanium Base for CEREC

K 號：K160964 · 2016-09-16

申請人Jjgc Industria E Comercio DE Materiais Dentarios S.A.
決定日期2016-09-16
產品代碼NHA
諮詢委員會DE
決定Substantially Equivalent

器材摘要

Neodent Implant System - Titanium Base for CEREC is the device name listed in this FDA 510(k) record. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K160964. 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 Neodent Implant System - Titanium Base for CEREC?

Neodent Implant System - Titanium Base for CEREC is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K160964.

When did Neodent Implant System - Titanium Base for CEREC receive FDA 510(k) clearance?

Neodent Implant System - Titanium Base for CEREC received FDA 510(k) clearance on 2016-09-16, under 510(k) number K160964.

Who is the listed applicant for Neodent Implant System - Titanium Base for CEREC?

The FDA 510(k) record lists Jjgc Industria E Comercio DE Materiais Dentarios S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neodent Implant System - Titanium Base for CEREC?

The FDA product code for Neodent Implant System - Titanium Base for CEREC is NHA.

相關臨床試驗

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其他以 Jjgc Industria E Comercio DE Materiais Dentarios S.A. 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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