FDA 510(k)

通用锥形连接器（CC）

K号: K200040 · 2020-03-30

决定日期2020-03-30

产品代码NHA

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决定实质等同

器械摘要

Universal Base Conical Connection (CC) is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AG. It received FDA 510(k) clearance on 2020-03-30 under 510(k) number K200040. 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 Universal Base Conical Connection (CC)?

Universal Base Conical Connection (CC) is a medical device that received FDA 510(k) clearance on 2020-03-30. The listed applicant is Nobel Biocare AG. The 510(k) number is K200040.

When did Universal Base Conical Connection (CC) receive FDA 510(k) clearance?

Universal Base Conical Connection (CC) received FDA 510(k) clearance on 2020-03-30, under 510(k) number K200040.

Who is the listed applicant for Universal Base Conical Connection (CC)?

The FDA 510(k) record lists Nobel Biocare AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Universal Base Conical Connection (CC)?

The FDA product code for Universal Base Conical Connection (CC) is NHA.

列明Nobel Biocare AG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。

K212125Nobel Biocare 牙齿种植系统组合 - MR 条件

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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