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 Toothbrush, Manual
510(k) Number K130186
Device Name DENTEK EASY BRUSH WITH FLUORIDE
Applicant
Den Tek Oral Care, Inc.
307 Excellence Way
Maryville,  TN  37801
Applicant Contact LINDA GILES
Correspondent
Den Tek Oral Care, Inc.
307 Excellence Way
Maryville,  TN  37801
Correspondent Contact LINDA GILES
Regulation Number872.6855
Classification Product Code
EFW  
Date Received01/25/2013
Decision Date 07/15/2013
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
-
-