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 cement, dental
510(k) Number K040236
Device Name PULPDENT VLC RESIN CEMENT
Applicant
PULPDENT CORPORATION
80 OAKLAND ST.
WATERTOWN,  MA  02472
Applicant Contact KENNETH J BERK
Correspondent
PULPDENT CORPORATION
80 OAKLAND ST.
WATERTOWN,  MA  02472
Correspondent Contact KENNETH J BERK
Regulation Number872.3275
Classification Product Code
EMA  
Date Received02/02/2004
Decision Date 04/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-