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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name material, tooth shade, resin
510(K) Number K121769
Device Name DENTOCORE/DENTOCORE BODY
Applicant
ITENA CLINICAL
500 boul cartier west
laval, 
Contact louis- paul marin
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/15/2012
Decision Date 03/05/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-