FDA 510(k)

Straumann® 解剖愈合基台 XC (AHA)

K号: K241575 · 2024-11-11

决定日期2024-11-11

产品代码NHA

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决定实质等同

器械摘要

Straumann® Anatomic Healing Abutments XC (AHA) is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC. It received FDA 510(k) clearance on 2024-11-11 under 510(k) number K241575. 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 Straumann® Anatomic Healing Abutments XC (AHA)?

Straumann® Anatomic Healing Abutments XC (AHA) is a medical device that received FDA 510(k) clearance on 2024-11-11. The listed applicant is Straumann USA, LLC. The 510(k) number is K241575.

When did Straumann® Anatomic Healing Abutments XC (AHA) receive FDA 510(k) clearance?

Straumann® Anatomic Healing Abutments XC (AHA) received FDA 510(k) clearance on 2024-11-11, under 510(k) number K241575.

Who is the listed applicant for Straumann® Anatomic Healing Abutments XC (AHA)?

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

What is the FDA product code for Straumann® Anatomic Healing Abutments XC (AHA)?

The FDA product code for Straumann® Anatomic Healing Abutments XC (AHA) is NHA.

列明Straumann USA, 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。

K203753Straumann 外科托盘 K202942Straumann 4 毫米短植入体 K192401Straumann 螺丝固定基台 K190662现有 Straumann 牙种植系统兼容 MRI K171784Straumann牙种植系统 K162890BLT 02.9mm SC, SLA 或 SLActive, RXD, Loxim, SC Closure Cap 和愈合基台, SC 临时基台, SC Variobase 基台, SC CARES 基台

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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。

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