FDA 510(k)

LuxCreo 弹性部分义齿树脂

K号: K253365 · 2025-11-25

决定日期2025-11-25

产品代码EBI

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决定实质等同

器械摘要

LuxCreo Flexible Partial Denture Resin is the device name listed in this FDA 510(k) record. The listed applicant is LuxCreo, Inc.. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K253365. 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 LuxCreo Flexible Partial Denture Resin?

LuxCreo Flexible Partial Denture Resin is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is LuxCreo, Inc.. The 510(k) number is K253365.

When did LuxCreo Flexible Partial Denture Resin receive FDA 510(k) clearance?

LuxCreo Flexible Partial Denture Resin received FDA 510(k) clearance on 2025-11-25, under 510(k) number K253365.

Who is the listed applicant for LuxCreo Flexible Partial Denture Resin?

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

What is the FDA product code for LuxCreo Flexible Partial Denture Resin?

The FDA product code for LuxCreo Flexible Partial Denture Resin is EBI.

列明LuxCreo, 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。

K250343LuxCreo 清晰正畸系统 K230592LuxCreo 牙齿夜护树脂 K212680LuxCreo 清晰正畸系统

官方来源

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