FDA 510(k)

Juell 3D Volo Base

K号: K181220 · 2018-10-12

决定日期2018-10-12

产品代码EBI

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决定实质等同

器械摘要

Juell 3D Volo Base is the device name listed in this FDA 510(k) record. The listed applicant is Park Dental Research Corporation. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K181220. 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 Juell 3D Volo Base?

Juell 3D Volo Base is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Park Dental Research Corporation. The 510(k) number is K181220.

When did Juell 3D Volo Base receive FDA 510(k) clearance?

Juell 3D Volo Base received FDA 510(k) clearance on 2018-10-12, under 510(k) number K181220.

Who is the listed applicant for Juell 3D Volo Base?

The FDA 510(k) record lists Park Dental Research Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Juell 3D Volo Base?

The FDA product code for Juell 3D Volo Base is EBI.

列明Park Dental Research Corporation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。

K233935DigiLine直接打印矫正器系统 K180648Park 牙科研究矫正器

官方来源

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