FDA 510(k)

Gradia Plus

K 號：K153325 · 2016-07-12

決定日期2016-07-12

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Gradia Plus is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2016-07-12 under 510(k) number K153325. 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 Gradia Plus?

Gradia Plus is a medical device that received FDA 510(k) clearance on 2016-07-12. The listed applicant is GC America, Inc.. The 510(k) number is K153325.

When did Gradia Plus receive FDA 510(k) clearance?

Gradia Plus received FDA 510(k) clearance on 2016-07-12, under 510(k) number K153325.

Who is the listed applicant for Gradia Plus?

FDA 510(k) 記錄將 GC America, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Gradia Plus?

The FDA product code for Gradia Plus is EBF.

其他以 GC America, Inc. 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：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

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