FDA 510(k)

Tetric CAD

K 號：K173573 · 2018-06-07

決定日期2018-06-07

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Tetric CAD 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 2018-06-07 under 510(k) number K173573. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tetric CAD?

Tetric CAD is a medical device that received FDA 510(k) clearance on 2018-06-07. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K173573.

When did Tetric CAD receive FDA 510(k) clearance?

Tetric CAD received FDA 510(k) clearance on 2018-06-07, under 510(k) number K173573.

Who is the listed applicant for Tetric CAD?

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 Tetric CAD?

The FDA product code for Tetric CAD is EBF.

其他以 Ivoclar Vivadent, AG 為申請人之記錄

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相關器械（代碼：EBF）

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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