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FDA 510(k)

DNA Appliance

K-Number: K222872 · 2022-12-30

ApplicantVivos Therapeutics, Inc.
Decision Date2022-12-30
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DNA Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Vivos Therapeutics, Inc.. It received FDA 510(k) clearance on 2022-12-30 under 510(k) 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. The listed applicant is Vivos Therapeutics, Inc.. The 510(k) number is K222872.

When did DNA Appliance receive FDA 510(k) clearance?

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

Who is the listed applicant for DNA Appliance?

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

What is the FDA product code for DNA Appliance?

The FDA product code for DNA Appliance is LRK.

Other records listing Vivos Therapeutics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234089DNA ApplianceK230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)

Related Devices (Code: LRK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

Official Source

View on FDA Database →

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

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