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 K172991
Device Name Advanced Dental Applicance
Applicant
Dasoft Partners
4079 Governer Dr.#111
San Diego,  CA  92122
Applicant Contact Dante Togliatti
Correspondent
Aschwartz Consulting
1225 Hall Rd.
West Chester,  PA  19380
Correspondent Contact Alyssa Schwartz
Regulation Number872.5570
Classification Product Code
LRK  
Date Received09/27/2017
Decision Date 07/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-