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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K222872
Device Name DNA Appliance
Applicant
Vivos Therapeutics, Inc.
300 S 5th St.
Murray,  KY  42017
Applicant Contact Kimberly Griffith
Correspondent
Colette Cozean, PHD
21581 Midcrest Dr.
Lake Forest,  CA  92630
Correspondent Contact Colette Cozean
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received09/22/2022
Decision Date 12/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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