• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name agent, polishing, abrasive, oral cavity
510(k) Number K033785
Device Name PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE
Original Applicant
DISCUS DENTAL, INC.
8550 higuera st.
culver city,  CA  90232 2522
Original Contact vivian lai
Regulation Number872.6030
Classification Product Code
EJR  
Date Received12/04/2003
Decision Date 06/18/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-