Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Device, Anti-Snoring
510(k) Number K234089
Device Name DNA Appliance
Applicant
Vivos Therapeutics
300 S 5th St.
Murray,  KY  42017
Applicant Contact Kimberly Griffith
Correspondent
The Eyedeas Company
21581 Midcrest Dr.
Lake Forest,  CA  92630
Correspondent Contact Coletter Cozean
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received12/22/2023
Decision Date 09/16/2024
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
-
-