FDA 510(k)

UltraPrint-Dental 牙科义齿紫外线

K号: K253324 · 2025-11-20

决定日期2025-11-20

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

UltraPrint-Dental Denture UV is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Heygears IMC., Inc.. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K253324. 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 UltraPrint-Dental Denture UV?

UltraPrint-Dental Denture UV is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Guangzhou Heygears IMC., Inc.. The 510(k) number is K253324.

When did UltraPrint-Dental Denture UV receive FDA 510(k) clearance?

UltraPrint-Dental Denture UV received FDA 510(k) clearance on 2025-11-20, under 510(k) number K253324.

Who is the listed applicant for UltraPrint-Dental Denture UV?

FDA 510(k)记录将广州海格智能医疗器械有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for UltraPrint-Dental Denture UV?

The FDA product code for UltraPrint-Dental Denture UV is EBI.

列明Guangzhou Heygears IMC., Inc.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。

K261626超印柔性义齿紫外线 K253798UltraPrint-Dental 硬式牙科夹板紫外线 K213643UltraPrint-Dental 牙科临时冠桥紫外线

官方来源

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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。