FDA 510(k)

Atlantis® 钛基台

K号: K252343 · 2025-12-09

决定日期2025-12-09

产品代码NHA

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决定实质等同

器械摘要

Atlantis® Abutments in Titanium is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2025-12-09 under 510(k) number K252343. 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?

Atlantis® Abutments in Titanium is a medical device that received FDA 510(k) clearance on 2025-12-09. The listed applicant is Dentsply Sirona. The 510(k) number is K252343.

When did Atlantis® Abutments in Titanium receive FDA 510(k) clearance?

Atlantis® Abutments in Titanium received FDA 510(k) clearance on 2025-12-09, under 510(k) number K252343.

Who is the listed applicant for Atlantis® Abutments in Titanium?

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?

The FDA product code for Atlantis® Abutments in Titanium 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 K252248CEREC Tessera基台系统 K251205Atlantis® 钛基台，用于 Straumann BLX 和 Neodent GM 植入体 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.

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