FDA 510(k)

Ultrafast, Ultrafast Plus, Ultrafast Lite

K-Number: K201387 · 2021-02-26

Decision Date2021-02-26

Product CodeNVK

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Dentlight, Inc.. The 510(k) number is K201387.

When was Ultrafast, Ultrafast Plus, Ultrafast Lite approved by the FDA?

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

What company makes Ultrafast, Ultrafast Plus, Ultrafast Lite?

Ultrafast, Ultrafast Plus, Ultrafast Lite is manufactured by Dentlight, Inc..

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

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.