FDA 510(k)

Cortex CAD/CAM 牙槽體

K 號：K181580 · 2019-01-29

申請人Cortex Dental Implants Industries , Ltd.

決定日期2019-01-29

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Cortex CAD/CAM Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Cortex Dental Implants Industries , Ltd.. It received FDA 510(k) clearance on 2019-01-29 under 510(k) number K181580. 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 Cortex CAD/CAM Abutments?

Cortex CAD/CAM Abutments is a medical device that received FDA 510(k) clearance on 2019-01-29. The listed applicant is Cortex Dental Implants Industries , Ltd.. The 510(k) number is K181580.

When did Cortex CAD/CAM Abutments receive FDA 510(k) clearance?

Cortex CAD/CAM Abutments received FDA 510(k) clearance on 2019-01-29, under 510(k) number K181580.

Who is the listed applicant for Cortex CAD/CAM Abutments?

The FDA 510(k) record lists Cortex Dental Implants Industries , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cortex CAD/CAM Abutments?

The FDA product code for Cortex CAD/CAM Abutments is NHA.

其他以 Cortex Dental Implants Industries , Ltd. 為申請人之記錄

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K163385Cortex 牙齒植體系統

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。

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官方來源

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