mmRNA appliance
K-Number: K210203 · 2021-08-19
Decision Date2021-08-19
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
mmRNA appliance is a medical device manufactured by Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I). It received FDA 510(k) clearance on 2021-08-19 under approval number K210203. 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 mmRNA appliance?
mmRNA appliance is a medical device that received FDA 510(k) clearance on 2021-08-19. It is manufactured by Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I). The 510(k) number is K210203.
When was mmRNA appliance approved by the FDA?
mmRNA appliance received FDA 510(k) clearance on 2021-08-19, under approval number K210203.
What company makes mmRNA appliance?
mmRNA appliance is manufactured by Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I).
What is the FDA product code for mmRNA appliance?
The FDA product code for mmRNA 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.