FDA 510(k)

美麗邦通用

K 號：K180803 · 2018-09-26

決定日期2018-09-26

產品代碼KLE

諮詢委員會DE

決定相當於

器材摘要

BeautiBond Universal 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 2018-09-26 under 510(k) number K180803. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BeautiBond Universal?

BeautiBond Universal is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Shofu Dental Corporation. The 510(k) number is K180803.

When did BeautiBond Universal receive FDA 510(k) clearance?

BeautiBond Universal received FDA 510(k) clearance on 2018-09-26, under 510(k) number K180803.

Who is the listed applicant for BeautiBond Universal?

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 BeautiBond Universal?

The FDA product code for BeautiBond Universal is KLE.

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

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相關器械（代碼：KLE）

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。

K262252MPa 最大膠粘劑Den-Mat Holdings, LLC K260485Any-EtchMediclus Co., Ltd.K260430瓷刻膠Belport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ 過敏性膠粘劑Premier Dental Products Company K251587VITA VMLC 基質Vita Zahnfabrik H. Rauter GmbH & Co. Kg.

官方來源

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