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FDA 510(k)

DNA Appliance

K-Number: K222872 · 2022-12-30

Decision Date2022-12-30
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DNA Appliance is a medical device manufactured by Vivos Therapeutics, Inc.. It received FDA 510(k) clearance on 2022-12-30 under approval number K222872. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DNA Appliance?

DNA Appliance is a medical device that received FDA 510(k) clearance on 2022-12-30. It is manufactured by Vivos Therapeutics, Inc.. The 510(k) number is K222872.

When was DNA Appliance approved by the FDA?

DNA Appliance received FDA 510(k) clearance on 2022-12-30, under approval number K222872.

What company makes DNA Appliance?

DNA Appliance is manufactured by Vivos Therapeutics, Inc..

What is the FDA product code for DNA Appliance?

The FDA product code for DNA Appliance is LRK.

Other Devices by Vivos Therapeutics, Inc.

Related Devices (Code: LRK)

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.