FDA 510(k)

Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT

K号: K231263 · 2024-01-05

决定日期2024-01-05

产品代码EBF

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决定实质等同

器械摘要

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.

常见问题

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.

列明Prevest Denpro Limited为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K233273C&B Ceramic；C&B Permanent；C&B Interim K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal K213244Accusil 牙科印模材料 (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 Paste, Zical Ultra Powder/Liquid K212475Prevest Denpro 腔隙衬垫（Apacal ART，Cal LC，Calcigel，CalUltra）K200555Prevest Denpro 牙科粘合剂（Micron 生物活性，Micron 优质，Micron 优质胶囊，Micron 粘合剂，Micron 牙本质调节剂）

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官方来源

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