FDA 510(k)

LOCATOR® 角形基台

K号: K252944 · 2025-10-15

决定日期2025-10-15

产品代码NHA

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

LOCATOR® Angled Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Zest Anchors, LLC. It received FDA 510(k) clearance on 2025-10-15 under 510(k) number K252944. 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 LOCATOR® Angled Abutment?

LOCATOR® Angled Abutment is a medical device that received FDA 510(k) clearance on 2025-10-15. The listed applicant is Zest Anchors, LLC. The 510(k) number is K252944.

When did LOCATOR® Angled Abutment receive FDA 510(k) clearance?

LOCATOR® Angled Abutment received FDA 510(k) clearance on 2025-10-15, under 510(k) number K252944.

Who is the listed applicant for LOCATOR® Angled Abutment?

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

What is the FDA product code for LOCATOR® Angled Abutment?

The FDA product code for LOCATOR® Angled Abutment is NHA.

列明Zest Anchors, 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。

K260555LOCATOR® 角形基台 K250721LOCATOR® 角形基台 K243272LOCATOR 角形基台 K233587LOCATOR 角形基台（多种）K220252高保留连接系统 K213391高保留连接系统

查看所有 9 个设备 →

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。