FDA 510(k)

nuance 全能

K 號：K162967 · 2017-03-24

決定日期2017-03-24

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

nuance UNIVERSAL is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Holdings, LLC. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162967. 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 nuance UNIVERSAL?

nuance UNIVERSAL is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Den-Mat Holdings, LLC. The 510(k) number is K162967.

When did nuance UNIVERSAL receive FDA 510(k) clearance?

nuance UNIVERSAL received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162967.

Who is the listed applicant for nuance UNIVERSAL?

FDA 510(k) 記錄將 Den-Mat Holdings, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for nuance UNIVERSAL?

The FDA product code for nuance UNIVERSAL is EBF.

其他以 Den-Mat Holdings, LLC 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。

K262252MPa 最大膠粘劑 K242097DenMat 大塊填充複合材

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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