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FDA 510(k)

Dentilube Spray

K-Number: K202689 · 2021-09-03

ApplicantOxy2plus, LLC
Decision Date2021-09-03
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

Dentilube Spray is a medical device manufactured by Oxy2plus, LLC. It received FDA 510(k) clearance on 2021-09-03 under approval number K202689. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dentilube Spray?

Dentilube Spray is a medical device that received FDA 510(k) clearance on 2021-09-03. It is manufactured by Oxy2plus, LLC. The 510(k) number is K202689.

When was Dentilube Spray approved by the FDA?

Dentilube Spray received FDA 510(k) clearance on 2021-09-03, under approval number K202689.

What company makes Dentilube Spray?

Dentilube Spray is manufactured by Oxy2plus, LLC.

What is the FDA product code for Dentilube Spray?

The FDA product code for Dentilube Spray is LFD.

Related Devices (Code: LFD)

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.