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 K182162
Device Name OptiBond eXTRa Universal
Applicant
Kerr Corporation
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact Mohammad Saad Ansari
Correspondent
Sybron Dental Specialties
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact Ardrena Jackson
Regulation Number872.3200
Classification Product Code
KLE  
Date Received08/10/2018
Decision Date 11/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-