FDA 510(k)

VELMENI 为牙医（V4D）

K号: K250753 · 2025-09-02

决定日期2025-09-02

产品代码MYN

咨询委员会RA

决定实质等同

器械摘要

VELMENI for DENTISTS (V4D) is the device name listed in this FDA 510(k) record. The listed applicant is Velmeni, Inc.. It received FDA 510(k) clearance on 2025-09-02 under 510(k) number K250753. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VELMENI for DENTISTS (V4D)?

VELMENI for DENTISTS (V4D) is a medical device that received FDA 510(k) clearance on 2025-09-02. The listed applicant is Velmeni, Inc.. The 510(k) number is K250753.

When did VELMENI for DENTISTS (V4D) receive FDA 510(k) clearance?

VELMENI for DENTISTS (V4D) received FDA 510(k) clearance on 2025-09-02, under 510(k) number K250753.

Who is the listed applicant for VELMENI for DENTISTS (V4D)?

FDA 510(k)记录将Velmeni, Inc.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 VELMENI for DENTISTS (V4D)?

The FDA product code for VELMENI for DENTISTS (V4D) is MYN.

列明Velmeni, 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。

K254096VELMENI为牙医（V4D）3D K252953Velmeni for Dentists (V4D) 根管牙周 K240003Velmeni牙科医生专用（V4D）

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。