FDA 510(k)

東洋化學 Rebase III

K 號：K190940 · 2019-10-04

決定日期2019-10-04

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

Tokuyama Rebase III 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 2019-10-04 under 510(k) number K190940. 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 Rebase III?

Tokuyama Rebase III is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Tokuyama Dental Corporation. The 510(k) number is K190940.

When did Tokuyama Rebase III receive FDA 510(k) clearance?

Tokuyama Rebase III received FDA 510(k) clearance on 2019-10-04, under 510(k) number K190940.

Who is the listed applicant for Tokuyama Rebase III?

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 Rebase III?

The FDA product code for Tokuyama Rebase III 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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