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 Activator, Ultraviolet, For Polymerization
510(k) Number K070373
Device Name APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W
Applicant
APOZA ENTERPRISE CO. LTD.
2904 N. BOLDT DR.
FLAGSTAFF,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
APOZA ENTERPRISE CO. LTD.
2904 N. BOLDT DR.
FLAGSTAFF,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received02/08/2007
Decision Date 03/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-