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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 K230947
Device Name C.A.R.E. Appliance (DNA, mRNA, mmRNA)
Vivos Therapeutics, Inc
300 S. 5th Street
Murray,  KY  42017
Applicant Contact Kimberly Griffith
Eyedeas Company
21581 Midcrest Dr
Lake Forest,  CA  92630
Correspondent Contact Colette Cozean
Regulation Number872.5570
Classification Product Code
Subsequent Product Code
Date Received04/04/2023
Decision Date 11/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No