FDA 510(k)

超快速、超快速加強版、超快速輕量版

K 號：K201387 · 2021-02-26

決定日期2021-02-26

產品代碼NVK

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Dentlight, Inc. 為申請人之記錄

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相關器械（代碼：NVK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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