• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name sealant, pit and fissure, and conditioner
510(k) Number K122521
Device Name PREVENT SEAL
Original Applicant
ITENA CLINICAL
500 boul cartier west
laval,  CA h7v 5b7
Original Contact louis-paul marin
Regulation Number872.3765
Classification Product Code
EBC  
Date Received08/20/2012
Decision Date 06/11/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-