• 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 K203462
Device Name Advanced Dental Appliance
DaSoft Partners
4079 Governor Drive #111
San Diego,  CA  92122
Applicant Contact Dante Togliatti
J Blane, LLC
980 N Sinagua Heights Dr
Flagstaff,  AZ  86004
Correspondent Contact Kimberly Lane
Regulation Number872.5570
Classification Product Code
Date Received11/24/2020
Decision Date 02/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No