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 Material, Impression
510(k) Number K073475
Device Name SYSTEM PLUS
Applicant
Continental Dental Laboratory
1873 Western Way
Torrance,  CA  90501
Applicant Contact KAREEN CHAMBERLAIN
Correspondent
Continental Dental Laboratory
1873 Western Way
Torrance,  CA  90501
Correspondent Contact KAREEN CHAMBERLAIN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received12/11/2007
Decision Date 03/10/2008
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
-
-