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 Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K014059
Device Name PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
Applicant
Pulpdent Corp.
80 Oakland St.
Watertown,  MA  02472
Applicant Contact KENNETH J BERK
Correspondent
Pulpdent Corp.
80 Oakland St.
Watertown,  MA  02472
Correspondent Contact KENNETH J BERK
Regulation Number872.3750
Classification Product Code
DYH  
Date Received12/10/2001
Decision Date 02/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-