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 K132599
Device Name SMILEBOND SYSTEM
Applicant
Millennium Company, LLC
40701 Woodward Ave., Suite 102
Bloomfield Hills,  MI  48302
Applicant Contact STEPHEN J GOLDNER, JD, RAC
Correspondent
Millennium Company, LLC
40701 Woodward Ave., Suite 102
Bloomfield Hills,  MI  48302
Correspondent Contact STEPHEN J GOLDNER, JD, RAC
Regulation Number872.3660
Classification Product Code
ELW  
Date Received08/20/2013
Decision Date 02/25/2014
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
-
-