FDA 510(k)

融合核心直流 Flo；融合 Flo；融合 Flo SE；融合 1 密封；Magna NT

K 號：K231263 · 2024-01-05

決定日期2024-01-05

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT is the device name listed in this FDA 510(k) record. The listed applicant is Prevest Denpro Limited. It received FDA 510(k) clearance on 2024-01-05 under 510(k) number K231263. 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 Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT?

Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT is a medical device that received FDA 510(k) clearance on 2024-01-05. The listed applicant is Prevest Denpro Limited. The 510(k) number is K231263.

When did Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT receive FDA 510(k) clearance?

Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT received FDA 510(k) clearance on 2024-01-05, under 510(k) number K231263.

Who is the listed applicant for Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT?

The FDA 510(k) record lists Prevest Denpro Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT?

The FDA product code for Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT is EBF.

其他以 Prevest Denpro Limited 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。

K233273C&B陶瓷；C&B永久；C&B臨時 K231696融合粘合5，融合理510(k)，融合理DC，更新MDP，更新通用 K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)K212563CalApex Calplus、Cerafill RCS、Endoseal、Nanoseal S、Zical Ultra 黏土、Zical Ultra 粉末/液體 K212475Prevest Denpro 腺體洞線材（Apacal ART、Cal LC、Calcigel、CalUltra）K200555Prevest Denpro 齒科膠水（Micron 生物活性膠水、Micron 高級膠水、Micron 高級膠水膠囊、Micron 黏合膠水、Micron 齒質調理劑）

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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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