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 K914325
Device Name ROOT CANAL FILLING CEMENT
Applicant
Confi-Dental Products Co.
385 S. Pierce Ave.
Colorado Tech Center
Louisville,  CO  80027
Applicant Contact SHARON A LUTTON
Correspondent
Confi-Dental Products Co.
385 S. Pierce Ave.
Colorado Tech Center
Louisville,  CO  80027
Correspondent Contact SHARON A LUTTON
Regulation Number872.3820
Classification Product Code
KIF  
Date Received09/26/1991
Decision Date 03/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-