FDA 510(k)

超快速，超快速加，超快速轻

K号: K201387 · 2021-02-26

决定日期2021-02-26

产品代码NVK

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决定实质等同

器械摘要

Ultrafast, Ultrafast Plus, Ultrafast Lite is the device name listed in this FDA 510(k) record. The listed applicant is Dentlight, Inc.. It received FDA 510(k) clearance on 2021-02-26 under 510(k) number K201387. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ultrafast, Ultrafast Plus, Ultrafast Lite?

Ultrafast, Ultrafast Plus, Ultrafast Lite is a medical device that received FDA 510(k) clearance on 2021-02-26. The listed applicant is Dentlight, Inc.. The 510(k) number is K201387.

When did Ultrafast, Ultrafast Plus, Ultrafast Lite receive FDA 510(k) clearance?

Ultrafast, Ultrafast Plus, Ultrafast Lite received FDA 510(k) clearance on 2021-02-26, under 510(k) number K201387.

Who is the listed applicant for Ultrafast, Ultrafast Plus, Ultrafast Lite?

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

What is the FDA product code for Ultrafast, Ultrafast Plus, Ultrafast Lite?

The FDA product code for Ultrafast, Ultrafast Plus, Ultrafast Lite is NVK.

列明Dentlight, 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。

K180065FUSION Plus 照明灯

相关器械（代码：NVK）

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。

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