FDA 510(k)

Atlantis® 钛基台，用于 Straumann BLX 和 Neodent GM 植入体

K号: K251205 · 2025-11-21

决定日期2025-11-21

产品代码NHA

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决定实质等同

器械摘要

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K251205. 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 Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants?

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Dentsply Sirona. The 510(k) number is K251205.

When did Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants receive FDA 510(k) clearance?

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants received FDA 510(k) clearance on 2025-11-21, under 510(k) number K251205.

Who is the listed applicant for Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants?

FDA 510(k)记录中列出Dentsply Sirona为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants?

The FDA product code for Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants is NHA.

列明Dentsply Sirona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。

K262127DS Core CBCT 解剖 K260785DS Core CBCT 解剖 K253959Primevision 3D K252343Atlantis® 钛基台 K252248CEREC Tessera基台系统 K250295Dentsply Sirona 钛基系统

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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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