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 K020171
Device Name COOLBLU2 DENTAL RESIN CURING DEVICE
Applicant
Dental Systems.Com, Inc.
1187 Tadsworth Terrace
Heathrow,  FL  32746
Applicant Contact SHINOBU DOI
Correspondent
Dental Systems.Com, Inc.
1187 Tadsworth Terrace
Heathrow,  FL  32746
Correspondent Contact SHINOBU DOI
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received01/17/2002
Decision Date 01/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-