FDA 510(k)

NobelProcera 钛合金 ASC 套管，Omnigrip 临床螺丝钛合金

K号: K233208 · 2024-01-24

决定日期2024-01-24

产品代码NHA

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决定实质等同

器械摘要

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2024-01-24 under 510(k) number K233208. 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 NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium?

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium is a medical device that received FDA 510(k) clearance on 2024-01-24. The listed applicant is Nobel Biocare AB. The 510(k) number is K233208.

When did NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium receive FDA 510(k) clearance?

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium received FDA 510(k) clearance on 2024-01-24, under 510(k) number K233208.

Who is the listed applicant for NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium?

FDA 510(k)记录显示诺贝尔生物护理AB为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium?

The FDA product code for NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium is NHA.

列明Nobel Biocare AB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。

K253988LiteSet托盘 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 K252197Nobel Biocare S 系列种植体 K243834NobelZygoma TiUltra 植入系统 K240346NobelProcera 氧化锆植入体桥 K231898DTX Studio 诊所（4.0）

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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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