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


New Search Back To Search Results
Device Classification Name material, impression
510(k) Number K113406
Device Name AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
Original Applicant
DENTSPLY INTERNATIONAL, INC.
221 w. philadelphia st., se 60
susquehanna commerce ctr.
york,  PA  17404
Original Contact helen lewis
Regulation Number872.3660
Classification Product Code
ELW  
Date Received11/18/2011
Decision Date 02/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-