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 Agent, Tooth Bonding, Resin
510(k) Number K982394
Device Name PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
Applicant
DENTSPLY INTL.
570 WEST COLLEGE AVE.
YORK,  PA  17405 -0872
Applicant Contact P.JEFFERY LEHN
Correspondent
DENTSPLY INTL.
570 WEST COLLEGE AVE.
YORK,  PA  17405 -0872
Correspondent Contact P.JEFFERY LEHN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/09/1998
Decision Date 09/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-