DNA Appliance
K-Number: K234089 · 2024-09-16
ApplicantVivos Therapeutics
Decision Date2024-09-16
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
DNA Appliance is a medical device manufactured by Vivos Therapeutics. It received FDA 510(k) clearance on 2024-09-16 under approval number K234089. 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 2024-09-16. It is manufactured by Vivos Therapeutics. The 510(k) number is K234089.
When was DNA Appliance approved by the FDA?
DNA Appliance received FDA 510(k) clearance on 2024-09-16, under approval number K234089.
What company makes DNA Appliance?
DNA Appliance is manufactured by Vivos Therapeutics.
What is the FDA product code for DNA Appliance?
The FDA product code for DNA Appliance is LRK.
Related Devices (Code: LRK)
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.