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 Alloy, Metal, Base
510(k) Number K862667
Device Name COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY
Applicant
Austenal Dental, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Applicant Contact MARK WOJTULEWICZ
Correspondent
Austenal Dental, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Correspondent Contact MARK WOJTULEWICZ
Regulation Number872.3710
Classification Product Code
EJH  
Date Received07/14/1986
Decision Date 07/31/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-