免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

义齿基托

K号: K243103 · 2024-12-23

决定日期2024-12-23
产品代码EBI
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

Denture Base is the device name listed in this FDA 510(k) record. The listed applicant is Riton 3D Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K243103. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Denture Base?

Denture Base is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Riton 3D Technology Co., Ltd.. The 510(k) number is K243103.

When did Denture Base receive FDA 510(k) clearance?

Denture Base received FDA 510(k) clearance on 2024-12-23, under 510(k) number K243103.

Who is the listed applicant for Denture Base?

The FDA 510(k) record lists Riton 3D Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Denture Base?

The FDA product code for Denture Base is EBI.

相关临床试验

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。

相关器械(代码:EBI)

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。

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。

↑