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 K940513
Device Name OPTIBOND
Applicant
Kerr Corporation (Danbury)
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Applicant Contact JEFFREY A ANDERSON
Correspondent
Kerr Corporation (Danbury)
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Correspondent Contact JEFFREY A ANDERSON
Regulation Number872.3200
Classification Product Code
KLE  
Date Received02/04/1994
Decision Date 04/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-