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 alloy, gold-based noble metal
510(K) Number K940856
Device Name AURIUM G13 (HIGH GOLD CROWN AND BRIDGE ALLOY)
Applicant
ARGEN PRECIOUS METALS, INC.
8380 miralani dr.
san diego,  CA  92126
Contact dr. manohar lal malhotra
Regulation Number872.3060
Classification Product Code
EJT  
Date Received02/23/1994
Decision Date 03/29/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-