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 Laser, Fluorescence Caries Detection
510(k) Number K063321
Device Name D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138
Applicant
Neks Technologies, Inc.
2816, Joseph A. Bombardier
Laval, Quebec,  CA H7P 6E2
Applicant Contact NAIM KARAZIVAN
Correspondent
Neks Technologies, Inc.
2816, Joseph A. Bombardier
Laval, Quebec,  CA H7P 6E2
Correspondent Contact NAIM KARAZIVAN
Regulation Number872.1745
Classification Product Code
NBL  
Date Received11/02/2006
Decision Date 03/30/2007
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
-
-