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 Abutment, Implant, Dental, Endosseous
510(k) Number K143051
Device Name ArgenIS Titanium Abutments
Applicant
THE ARGEN CORPORATION
5855 OBERLIN DRIVE
SAN DIEGO,  CA  92121
Applicant Contact Maria Rao
Correspondent
THE ARGEN CORPORATION
5855 OBERLIN DRIVE
SAN DIEGO,  CA  92121
Correspondent Contact Maria Rao
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/23/2014
Decision Date 09/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-