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 Resin, Root Canal Filling
510(k) Number K120048
Device Name DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
Applicant
Drfp , Ltd.
Amstel 320-I
Amsterdam,  GB 1017 AP
Applicant Contact DAGMAR MAESER
Correspondent
Drfp , Ltd.
Amstel 320-I
Amsterdam,  GB 1017 AP
Correspondent Contact DAGMAR MAESER
Regulation Number872.3820
Classification Product Code
KIF  
Date Received01/06/2012
Decision Date 06/20/2012
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
-
-