FDA 510(k)

勝利樹脂阻隔器

K 號：K151945 · 2016-02-18

決定日期2016-02-18

產品代碼EIE

諮詢委員會DE

決定相當於

器材摘要

Triumph Resin Dam is the device name listed in this FDA 510(k) record. The listed applicant is Denali Corporation. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K151945. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Triumph Resin Dam?

Triumph Resin Dam is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Denali Corporation. The 510(k) number is K151945.

When did Triumph Resin Dam receive FDA 510(k) clearance?

Triumph Resin Dam received FDA 510(k) clearance on 2016-02-18, under 510(k) number K151945.

Who is the listed applicant for Triumph Resin Dam?

The FDA 510(k) record lists Denali Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Triumph Resin Dam?

The FDA product code for Triumph Resin Dam is EIE.

其他以 Denali Corporation 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。

K153191鈣橋

相關器械（代碼：EIE）

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。

K182118盔甲LCMavrik Dental Systems, Ltd.

官方來源

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