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 Sealant, Pit And Fissure, And Conditioner
510(k) Number K172169
Device Name Pulpdent (Activa) Pit and Fissure Sealant with MCP
Applicant
Pulpdent Corporation
80 Oakland St.
Watertown,  MA  02472
Applicant Contact Kenneth J. Berk
Correspondent
Medtek, LLC
2516 Kettle Creek Ct.
Lincolnton,  NC  28092
Correspondent Contact Roger Mastrony
Regulation Number872.3765
Classification Product Code
EBC  
Subsequent Product Code
EBF  
Date Received07/18/2017
Decision Date 01/05/2018
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
-
-