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 Varnish, Cavity
510(k) Number K901049
Device Name COPAL VARNISH
Applicant
PULPDENT CORP.
80 OAKLAND ST.
P.O. BOX 780
WATERTOWN,  MA  02471 -0780
Applicant Contact KENNETH J BERK
Correspondent
PULPDENT CORP.
80 OAKLAND ST.
P.O. BOX 780
WATERTOWN,  MA  02471 -0780
Correspondent Contact KENNETH J BERK
Regulation Number872.3260
Classification Product Code
LBH  
Date Received03/05/1990
Decision Date 05/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-