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 Handle, Instrument, Dental
510(k) Number K140144
Device Name BENDA WEDGE
Applicant
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484 -5458
Applicant Contact GREG MOREAU
Correspondent
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484 -5458
Correspondent Contact GREG MOREAU
Regulation Number872.4565
Classification Product Code
EJB  
Date Received01/22/2014
Decision Date 07/08/2014
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
-
-