FDA 510(k)

HC 前置器

K 號：K161891 · 2016-11-21

決定日期2016-11-21

產品代碼KLE

諮詢委員會DE

決定相當於

器材摘要

HC Primer 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 2016-11-21 under 510(k) number K161891. 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 HC Primer?

HC Primer is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Shofu Dental Corporation. The 510(k) number is K161891.

When did HC Primer receive FDA 510(k) clearance?

HC Primer received FDA 510(k) clearance on 2016-11-21, under 510(k) number K161891.

Who is the listed applicant for HC Primer?

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 HC Primer?

The FDA product code for HC Primer 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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