FDA 510(k)

NextDent 喷射假牙基础；NextDent 喷射假牙牙齿

K号: K241071 · 2024-09-04

决定日期2024-09-04

产品代码EBI

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决定实质等同

器械摘要

NextDent Jet Denture Base; NextDent Jet Denture Teeth is the device name listed in this FDA 510(k) record. The listed applicant is Vertex-Dental B.V.. It received FDA 510(k) clearance on 2024-09-04 under 510(k) number K241071. 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 NextDent Jet Denture Base; NextDent Jet Denture Teeth?

NextDent Jet Denture Base; NextDent Jet Denture Teeth is a medical device that received FDA 510(k) clearance on 2024-09-04. The listed applicant is Vertex-Dental B.V.. The 510(k) number is K241071.

When did NextDent Jet Denture Base; NextDent Jet Denture Teeth receive FDA 510(k) clearance?

NextDent Jet Denture Base; NextDent Jet Denture Teeth received FDA 510(k) clearance on 2024-09-04, under 510(k) number K241071.

Who is the listed applicant for NextDent Jet Denture Base; NextDent Jet Denture Teeth?

The FDA 510(k) record lists Vertex-Dental B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NextDent Jet Denture Base; NextDent Jet Denture Teeth?

The FDA product code for NextDent Jet Denture Base; NextDent Jet Denture Teeth is EBI.

列明Vertex-Dental B.V.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。

K231388NextDent 基础版 K221022NextDent 正畸柔性 K191497NextDent 假牙 3D+K162572NextDent 假牙，E-Denture

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。