FDA 510(k)

IPS e.max® 压克力基座臥臥牙根板解決方案用於Viteo Base Ti

K 號：K160798 · 2016-12-15

決定日期2016-12-15

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

IPS e.max® Press Abutment Solutions for Viteo Base Ti is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K160798. 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 IPS e.max® Press Abutment Solutions for Viteo Base Ti?

IPS e.max® Press Abutment Solutions for Viteo Base Ti is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K160798.

When did IPS e.max® Press Abutment Solutions for Viteo Base Ti receive FDA 510(k) clearance?

IPS e.max® Press Abutment Solutions for Viteo Base Ti received FDA 510(k) clearance on 2016-12-15, under 510(k) number K160798.

Who is the listed applicant for IPS e.max® Press Abutment Solutions for Viteo Base Ti?

The FDA 510(k) record lists Ivoclar Vivadent, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPS e.max® Press Abutment Solutions for Viteo Base Ti?

The FDA product code for IPS e.max® Press Abutment Solutions for Viteo Base Ti is NHA.

其他以 Ivoclar Vivadent, AG 為申請人之記錄

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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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