FDA 510(k)

ZENEX FreeMilling & CCM 銅結牙根座

K 號：K231557 · 2023-08-24

決定日期2023-08-24

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

ZENEX FreeMilling & CCM Cast Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Izenimplant Co., Ltd.. It received FDA 510(k) clearance on 2023-08-24 under 510(k) number K231557. 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 ZENEX FreeMilling & CCM Cast Abutment?

ZENEX FreeMilling & CCM Cast Abutment is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Izenimplant Co., Ltd.. The 510(k) number is K231557.

When did ZENEX FreeMilling & CCM Cast Abutment receive FDA 510(k) clearance?

ZENEX FreeMilling & CCM Cast Abutment received FDA 510(k) clearance on 2023-08-24, under 510(k) number K231557.

Who is the listed applicant for ZENEX FreeMilling & CCM Cast Abutment?

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

What is the FDA product code for ZENEX FreeMilling & CCM Cast Abutment?

The FDA product code for ZENEX FreeMilling & CCM Cast Abutment is NHA.

其他以 Izenimplant Co., Ltd. 為申請人之記錄

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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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