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 Caries Detector, Laser Light, Transmission
510(k) Number K062961
Device Name MICROLUX TRANSILLUMINATOR
Applicant
ADDENT, INC.
43 MIRY BROOK RD.
DANBURY,  CT  06810
Applicant Contact JOSHUA FRIEDMAN
Correspondent
ADDENT, INC.
43 MIRY BROOK RD.
DANBURY,  CT  06810
Correspondent Contact JOSHUA FRIEDMAN
Regulation Number872.1745
Classification Product Code
NTK  
Date Received09/29/2006
Decision Date 02/08/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-