• 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 locator, root apex
510(k) Number K945811
Device Name PULPDENT CANAL FINDER
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
Classification Product Code
LQY  
Date Received11/28/1994
Decision Date 01/20/1995
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-