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 Bracket, Ceramic, Orthodontic
510(k) Number K160957
Device Name CDB Self Ligating Bracket 8F
Applicant
Cdb Corporation
9201 Industrial Blvd., NE
Leland,  NC  28451
Applicant Contact YANNIRE THOMPSON
Correspondent
Cdb Corporation
9201 Industrial Blvd., NE
Leland,  NC  28451
Correspondent Contact YANNIRE THOMPSON
Regulation Number872.5470
Classification Product Code
NJM  
Date Received04/05/2016
Decision Date 09/27/2016
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
-
-