FDA 510(k)

東洋化學 CUREGRACE

K 號：K170549 · 2017-07-05

決定日期2017-07-05

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

TOKUYAMA CUREGRACE is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2017-07-05 under 510(k) number K170549. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TOKUYAMA CUREGRACE?

TOKUYAMA CUREGRACE is a medical device that received FDA 510(k) clearance on 2017-07-05. The listed applicant is Tokuyama Dental Corporation. The 510(k) number is K170549.

When did TOKUYAMA CUREGRACE receive FDA 510(k) clearance?

TOKUYAMA CUREGRACE received FDA 510(k) clearance on 2017-07-05, under 510(k) number K170549.

Who is the listed applicant for TOKUYAMA CUREGRACE?

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

What is the FDA product code for TOKUYAMA CUREGRACE?

The FDA product code for TOKUYAMA CUREGRACE is EBI.

其他以 Tokuyama Dental 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。

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相關器械（代碼：EBI）

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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