FDA 510(k)

LuxCreo 牙齿夜护树脂

K号: K230592 · 2024-01-18

决定日期2024-01-18

产品代码MQC

决定实质等同

器械摘要

LuxCreo Dental Night Guard 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 2024-01-18 under 510(k) number K230592. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常见问题

What is the LuxCreo Dental Night Guard Resin?

LuxCreo Dental Night Guard Resin is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is LuxCreo, Inc.. The 510(k) number is K230592.

When did LuxCreo Dental Night Guard Resin receive FDA 510(k) clearance?

LuxCreo Dental Night Guard Resin received FDA 510(k) clearance on 2024-01-18, under 510(k) number K230592.

Who is the listed applicant for LuxCreo Dental Night Guard 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 Dental Night Guard Resin?

The FDA product code for LuxCreo Dental Night Guard Resin is MQC.

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。

K253365LuxCreo 弹性部分义齿树脂 K250343LuxCreo 清晰正畸系统 K212680LuxCreo 清晰正畸系统

官方来源

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