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 Mouthguard, Over-The-Counter
510(k) Number K123849
Device Name NEW COMFORT-FIT DENTAL GUARD
Applicant
DENTEK ORAL CARE, INC.
307 EXCELLENCE WAY
MARYVILLE,  TN  37801
Applicant Contact LINDA GILES
Correspondent
DENTEK ORAL CARE, INC.
307 EXCELLENCE WAY
MARYVILLE,  TN  37801
Correspondent Contact LINDA GILES
Classification Product Code
OBR  
Date Received12/14/2012
Decision Date 01/10/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-