FDA 510(k)

適合SA

K 號：K182869 · 2019-01-09

決定日期2019-01-09

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Fit SA is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2019-01-09 under 510(k) number K182869. 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 Fit SA?

Fit SA is a medical device that received FDA 510(k) clearance on 2019-01-09. The listed applicant is Shofu Dental Corporation. The 510(k) number is K182869.

When did Fit SA receive FDA 510(k) clearance?

Fit SA received FDA 510(k) clearance on 2019-01-09, under 510(k) number K182869.

Who is the listed applicant for Fit SA?

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

What is the FDA product code for Fit SA?

The FDA product code for Fit SA is EBF.

其他以 Shofu 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。

K252808玻璃離子FX-LC K252165ZIRCONOMER P K251470ResiCem EX K251578BEAUTIFIL II K233161BeautiLink SA K222253玻璃離子FX超級

查看所有 23 項裝置 →

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。

K262982Core·it雙用式醫療設備規範文本Spident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695流動性修復材質（KP-Flow LF，KP-Flow MF，KP-Flow HF）Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus 填充劑；Tetric plus 流動劑Ivoclar Vivadent, Inc.K262228超越大量填充濃縮複合材料Ultradent Products, Inc.K261246SRGC-06GC America, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。