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 K172430
Device Name ArgenIS Titanium Abutments
Applicant
Argen Corporation
5855 Oberlin Dr.
San Diego,  CA  92121
Applicant Contact Paul Cascone
Correspondent
Sterngold Dental, LLC
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Correspondent Contact Gordon Craig
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/11/2017
Decision Date 05/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-