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 Varnish, Cavity
510(k) Number K153334
Device Name Oral-B 5% Sodium Fluoride Varnish
Applicant
Young Dental Manufacturing Co. 1, LLC
13705 Shoreline Ct. E.
Earth City,  MO  63045
Applicant Contact Sarah Moore
Correspondent
Young Dental Manufacturing Co. 1, LLC
13705 Shoreline Ct. E.
Earth City,  MO  63045
Correspondent Contact Sarah Moore
Regulation Number872.3260
Classification Product Code
LBH  
Date Received11/19/2015
Decision Date 05/20/2016
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
Recalls CDRH Recalls
-
-