FDA 510(k)

Bonafix植入体基台

K号: K251294 · 2025-10-15

决定日期2025-10-15

产品代码NHA

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决定实质等同

器械摘要

Bonafix Implant Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Zentek Medical, LLC. It received FDA 510(k) clearance on 2025-10-15 under 510(k) number K251294. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bonafix Implant Abutments?

Bonafix Implant Abutments is a medical device that received FDA 510(k) clearance on 2025-10-15. The listed applicant is Zentek Medical, LLC. The 510(k) number is K251294.

When did Bonafix Implant Abutments receive FDA 510(k) clearance?

Bonafix Implant Abutments received FDA 510(k) clearance on 2025-10-15, under 510(k) number K251294.

Who is the listed applicant for Bonafix Implant Abutments?

The FDA 510(k) record lists Zentek Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bonafix Implant Abutments?

The FDA product code for Bonafix Implant Abutments is NHA.

列明Zentek Medical, LLC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。

K221673Bonafix TiBase K213677Bonafix 2 Plus

相关器械（代码：NHA）

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。

K262207水泥固定基台Unidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC K253999通用底座 ASC 启动；通用底座 ASC 非启动；通用底座 MUA ASC；临时基台启动和非启动；愈合基台锥形连接；Omnigrip 临床螺丝钛；Omnigrip 假体螺丝Nobel Biocare AB K261147Neodent植入系统 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

官方来源

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