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 K903538
Device Name WIRON 99 DENTAL CASTING ALLOY
Applicant
Leach and Dillon Co., Inc.
171 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact AGARWAL, PH.D.
Correspondent
Leach and Dillon Co., Inc.
171 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact AGARWAL, PH.D.
Regulation Number872.3710
Classification Product Code
EJH  
Date Received08/07/1990
Decision Date 03/15/1991
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
-
-