FDA 510(k)

AA 临时修复 3D 打印光敏树脂

K号: K191590 · 2020-05-05

决定日期2020-05-05

产品代码EBG

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决定实质等同

器械摘要

AA temp temporary restoration 3D printing photoreactive resin is the device name listed in this FDA 510(k) record. The listed applicant is Enlighten Materials Co., Ltd.. It received FDA 510(k) clearance on 2020-05-05 under 510(k) number K191590. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AA temp temporary restoration 3D printing photoreactive resin?

AA temp temporary restoration 3D printing photoreactive resin is a medical device that received FDA 510(k) clearance on 2020-05-05. The listed applicant is Enlighten Materials Co., Ltd.. The 510(k) number is K191590.

When did AA temp temporary restoration 3D printing photoreactive resin receive FDA 510(k) clearance?

AA temp temporary restoration 3D printing photoreactive resin received FDA 510(k) clearance on 2020-05-05, under 510(k) number K191590.

Who is the listed applicant for AA temp temporary restoration 3D printing photoreactive resin?

The FDA 510(k) record lists Enlighten Materials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AA temp temporary restoration 3D printing photoreactive resin?

The FDA product code for AA temp temporary restoration 3D printing photoreactive resin is EBG.

列明Enlighten Materials Co., Ltd.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。

K191591BB 基础 3D 打印树脂，用于义齿基座

官方来源

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